The device was not returned so an evaluation could not be performed.Manufacturing records and complaint history could not be reviewed as lot# was not provided.Complaint history was reviewed for the corresponding catalog number, and no adverse trends were observed.Per additional correspondence with the field representative, the patient did not experience an external trauma post initial surgery.Operative notes and x-rays were not provided.It is unknown how the bone was prepared and how the screw was inserted during initial surgery.Patient's bone quality is unknown.Due to lack of information, an exact cause of the reported event could not be determined.Potential causes include: poor bone quality of patient, patient experiences external trauma/ performs high intensity post-op activity, instable construct and inadequate bone preparation during the initial surgery.
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