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Catalog Number 179712740S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Osteolysis (2377)
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Event Date 02/22/2024 |
Event Type
Injury
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Event Description
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Device report from synthes reports an event in ireland as follows: it was reported that the revision fusion was undertaken and all existing inner set screws and rods were removed.All screws appeared intact, and the surgeon pulled on each screw to double check its integrity.Upon pulling on the screw at l3 on the left side, the polyaxial component came away.The surgeon proceeded to insert new screws caudally and cranially and opted to leave the distal screw shaft in situ.Revision surgery was performed to treat adjacent segment issues by inserting new screws caudally and cranially.The distal component of the broken screw remained in the patient.There was a consequence for the patient as it resulted in a second procedure.A broken component of the screw remained in the patient.There was no surgical delay.This report is for one (1) unk mono/polyaxial screws.This is report 1 of 4 for complaint (b)(4).
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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.D1, d2, d3, d4, g4-510k: this report is for an unknown mono/polyaxial screws (unk construct expedium)/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6: 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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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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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Product remains insitu in patient.The patient is stable.
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Search Alerts/Recalls
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