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Catalog Number 296.766S |
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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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.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.(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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient underwent a procedure on an unknown date for fixation of a bilateral sacral fracture, utilizing a sacral bar implant 260 mm with nuts and washers (stainless steel).Postoperatively, the patient presented an implant loosening.Reoperation was due to loosening of sacral bar.There was an unknown healing of fracture reported.Patient outcome is unknown.No further information is available.This report involves one (1) 6.0mm threaded sacral bar 260mm.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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