Consumers and health professionals are advised that Medtronic, in consultation with the TGA, has initiated a recall of unused stock of multiple lots of its Infuse/LT-Cage Bone Graft Kit. Medtronic has also issued a related hazard alert to hospitals and surgeons.
Infuse/LT-Cage Bone Graft Kits include multiple components, including Absorbable Collagen Sponge (ACS), which are used in spinal fusion surgery to treat chronic back pain and related problems.
Integra LifeSciences Corporation has identified a potential issue with multiple lots of ACS it has supplied to Medtronic. A deviation in the production process may have resulted in ACS being released with endotoxin levels that are slightly higher than the product's specification.
No reports of patient injuries or other adverse events associated with this issue have been reported in Australia or overseas.
However, if ACS from any of the following lots is implanted there is potential for the patient to develop a fever immediately after the surgery:
- M111052AAM
- M111052AAT
- M111054AAR
- M111059AAE
- M111063AAE
- M111063AAF
- M111063AAK
- M111063AAO
- M111064AAH
- M111064AAN
- M111103AAC
Information for consumers
The risk of a patient developing a fever as a result of the above issue is only present immediately after the surgery.
Medtronic has contacted surgeons and the hospitals where the affected kits have been used, providing further information regarding this recall and advice on how to treat potentially affected patients.
If you have had spinal fusion surgery and have any questions or concerns, contact your surgeon or the hospital where the surgery was undertaken.
Information for all health professionals
Patients who have had spinal fusion surgery and who have any questions or concerns about the above issue should be referred to their surgeon or the hospital where the surgery was undertaken.
Medtronic has contacted surgeons and the hospitals where the affected kits have been used, providing further information regarding this recall and advice on how to treat potentially affected patients.
Information for surgeons and hospitals
Medtronic has written to surgeons and the hospitals where the affected kits have been used, providing further information about this issue and details of the recall process.
Surgeons and hospitals should check any unused Infuse/LT-Cage Bone Graft Kits they have in stock to see if any are from an affected lot. If they are, those kits should not be used. Instead, they should be quarantined before being returned to Medtronic.
Surgeons who have already used an affected kit are advised to monitor their patients for fever in the immediate postoperative period, in accordance with the standard hospital or clinical protocol.
Surgeons and hospitals should report any injuries or adverse events relating to the use of Infuse/LT-Cage Bone Graft Kits.
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.