Part: 04.168.295s, lot: l942452, manufacturing site: (b)(4), release to warehouse date: july 02, 2018, expiry date: may 31, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.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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It was reported that on (b)(6) 2020, the patient underwent removal of the femoral neck system (fns) devices and subsequent total hip arthroplasty due to hip pain and cystic changes.Initially, the reported devices were implanted on (b)(6) 2019 due to a femoral neck fracture.None of the reported devices were broken; they came out very easy and did not result in any further complications.Procedure was completed successfully.This report is for a bolt for femoral neck system.This is report 1 of 4 for (b)(4).
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