Model Number 186770040 |
Device Problem
Separation Failure (2547)
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Patient Problems
Injury (2348); Device Embedded In Tissue or Plaque (3165)
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Event Date 09/09/2017 |
Event Type
Injury
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Manufacturer Narrative
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Device is returned for evaluation.Investigation will be conducted.Follow up will be filed with the findings.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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Post-op films the day after the case, revealed that the x-tabs on the left side of the construct did not fully break off the screw.They broke off just above the threads.The patient was taken back into surgery the next day to remove the remainder of the x-tab.
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Manufacturer Narrative
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Visual examination of the broken tab revealed the it was broken above the intended breaking point.A review of the device history record could not be performed as the lot number was not provided.A trend analysis was conducted.No emerging trends were found requiring further actions.The investigation could not verify or identify any evidence of product contribution to the reported event.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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