Model Number N/A |
Device Problem
Disassembly (1168)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/04/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Event Description
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It was reported that the set screw detached from the plate during assembly while being implanted into the patient.The plate and set screw were removed and replaced with a new assembly.There were no reports of patient injury or surgical delay associated with this event.
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Manufacturer Narrative
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The returned plate assembly was evaluated.The set screw was found assembled as expected and no discrepancies were detected.The complaint could not be confirmed.A review of the manufacturing records did not identify any issues which may have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.
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Search Alerts/Recalls
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