Method: device not returned.Results: the univise spinous process fixation plate, 40mm was confirmed to disassemble during surgery by sales rep report and by a picture of the disassembled device provided by the sales rep.However, three requests for return of the device were made and it was not received.Furthermore, no anomalies were identified in the manufacturing files for the reported lot that may have contributed to the event.Additionally it was reported that the superior and inferior spinous processes that the plate was being attached to were of significantly different thickness.The plates were opening and closing properly, however the plates could not fit to the patient anatomy.This led to excessive force being applied to the device and caused disassembly.Conclusion: this issue is related to improper implant selection and patient anatomy.
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