A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device discarded.
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Procedure: cervical corpectomy.The patient was previously operated on (b)(6) 2017 for a 3/4 cervical fusion, 4/5 cervical disc arthroplasty and c5-7 cervical fusion.On the day the c5-7 fusion resulted in a corpectomy of c6 and a bengal stackable cage and skyline plate was implanted.The patient has presented with cage subsidence at c5-7.The surgeon has indicated that this was not a result of implant failure but due to the patient poor quality bone.Subsequently the c5-7 skyline plate and cage has been removed, a corpectomy of c7 has been performed and a longer stackable cage and plate has been implanted.Unfortunately the nurse had disposed of the implants so they are not able to be returned, however as stated earlier the surgeon has said that the subsidence was not due to any implant failure but due to poor bone quality.
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