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Consumers and health professionals are advised that B Braun Australia, in consultation with the TGA, has issued a hazard alert for certain lots of Samarys polyethylethylketone (PEEK) anterior cervical cage manufactured between April 2014 and November 2015. B Braun Australia is also recalling unused stock of potentially affected devices.
Samarys PEEK anterior cervical cage are implanted medical devices used in spinal fusion surgery. The cage possesses a large central cavity where bone graft or a substitute is embedded, allowing for a bone synthesis between the adjacent vertebral endplates.
It has been identified that very small gold wires used as a position marker within the affected devices may be missing, improperly secured and/or incorrectly positioned. The gold wires may protrude 1-2 mm inside or outside the device.
If this occurs, the patient may experience inflammation and/or neural or vascular injuries. In some improbable cases, the effectiveness of the bone graft could be affected, leading to potential weak spots within the fusion.
In rare cases where the gold wire moves, symptoms may include difficulty or discomfort swallowing, sensation of foreign bodies in their throat, or a suspect cough.
If the gold wires are missing or move, this will provide false information regarding the cage's position to a surgeon. If the surgeon can no longer accurately locate the cage, it could lead to unnecessary revision surgery.
Please note that the potential adverse events described above are theoretical and the likelihood of any of them occurring is very low. To 18 December 2015, there have been no reports of adverse events in Australia or overseas related to this issue.
| Part number | Lot numbers |
|---|---|
| 11CC2A15-5S | 23LJ-19196 |
| 11CC2A17-6S | 23KY+19029 |
| 11CC2AC17-5S | 247P+19029 |
| 11CC2AC17-6S | 248K+19029 |
Information for consumers
The probability of a patient experiencing a problem as a result of this issue is very low. No adverse events related to this issue have been reported to date.
If you or someone you care for has had spinal fusion surgery (specifically in the part of the spine commonly referred to as the neck) and are experiencing inflammation at the treated site or suspected symptoms (such as difficulty or discomfort swallowing, sensation of foreign bodies in their throat, or a suspect cough), or if you have any questions or concerns, contact your surgeon or the hospital where the surgery was undertaken.
Information for all health professionals
If you are treating a patient who has had a Samarys PEEK anterior cervical cage implanted and is concerned about this issue, reassure them that the probability of them experiencing a problem as a result of this issue is very low. No adverse events related to this issue have been reported to date and not all references or lots of this device are affected by this issue.
The potential adverse events described above are theoretical and very improbable. These problems would also be easily detected on routine X-rays.
If they continue to have questions or concerns about this issue, or if they are experiencing inflammation at the treated site or suspected symptoms (such as difficulty or discomfort swallowing, sensation of foreign bodies in their throat, or a suspect cough), refer them to their surgeon or the hospital where the surgery was undertaken.
Information for surgeons
B Braun Australia has written to surgeons who have implanted Samarys PEEK anterior cervical cages, providing detailed information about this issue.
If you are treating a patient who has a Samarys PEEK anterior cervical cage from an affected lot, advise them of this issue. However, reassure them that the probability of them experiencing a problem as a result of this issue is very low. No adverse events related to this issue have been reported to date and not all references or lots of this device are affected by this issue.
Instruct them to report any late dysphagia, sensation of foreign bodies into their throat or suspect cough, as well as any other unusual symptom in their throat or neck.
Affected patients can be asymptomatic for long periods.
Be aware that if the gold wires are missing or have migrated, this will provide false information about cage position, therefore comparing two consecutive X-rays may help.
The potential adverse events described above are theoretical and very improbable. These problems would also be easily detected on routine X-rays.
If you have any questions or concerns about this issue, contact B Braun Australia on 02 9629 0200 or email info.au@bbraun.com.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.