Model Number 186731545 |
Device Problem
Disassembly (1168)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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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During screw insertion, surgeon used expedium quick connect polyaxial screwdriver t20 to remove and adjust the placement of screws a couple of time.The damage screw was discovered during the insertion of rod.The damaged screw has to be removed as it obstructed the placement of rod.Patient consequence? :unknown.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
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Manufacturer Narrative
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Product complaint # (b)(4).Visual examination found no device failure.Swage markings were present indicative of the inner cap being properly placed in its intended position within the tulip head.Therefore, the reported device failure cannot be confirmed as no device failure was present during evaluation.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A root cause analysis is not required as there was no device failure noted during device evaluation.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.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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