Model Number 199723540S |
Device Problem
Device Slipped (1584)
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Patient Problem
Failure of Implant (1924)
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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.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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It was reported that on (b)(6) 2020 the patient had loosening of screws and required a re-arthrodesis.All screws were successfully removed from left/right - l3, l4, l5, s1, il.There was a five (5) minute surgical delay and procedure outcome was unknown.There was no patient harm/consequence.Concomitant devices: expedium 5.5mm titanium rods(part # unknown, lot # unknown, quantity # 2); 5.5 exp verse unitized set scr (part # 199721001, lot # unknown, quantity # 8); single-inner setscrew (part # 179702000, lot # unknown, quantity # 2).This report is for one (1) 5.5 exp verse fen scr 5.0x40.This is report 6 of 8 for (b)(4).
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Event Description
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Updated concomitant device reported: expedium 5.5mm titanium rods (part unknown, lot unknown, quantity 2); 5.5 exp verse unitized set screw (part 199721001, lot unknown, quantity 8); single-inner setscrew (part 179702000, lot unknown, quantity 2); 5.5 exp verse fen screw 7.0x40 (part 199723740s, lot unknown, quantity 2).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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