(b)(4).Device was not returned for evaluation.A photocopy of the x-ray was provided which revealed the loosening and migration of the reported connector extension.A review of the device history record could not be performed as the lot number is unknown.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause cannot be determined with the information provided.In general, patient factors that may affect the performance of the components include patient anatomy, bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history.Rehabilitation protocol and adherence thereto are unknown.As no systemic trends were found, this complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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