DEPUY SPINE INC UNKNOWN RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Device Problem
Device Slipped (1584)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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It was reported that on an (b)(6) 2022 , the patient is being brought back for a 3rd surgery (2nd to address the same issue).The rod has once again migrated in the tulip head suggesting loosening.This report captures the reported 3rd surgery of rod migration, while related complaint (b)(4) captures the reported second surgery.This report is for one (1) unknown rods this is report 3 of 3 for complaint (b)(4).
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Manufacturer Narrative
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Additional narrative: 510k: this report is for an unknown rod/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.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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Search Alerts/Recalls
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