Catalog Number 18955001S |
Device Problem
Bent (1059)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/19/2018 |
Event Type
Injury
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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It was reported that after the first revision surgery((b)(6) 2018), breakage of the screw which was replaced in the revision surgery and most proximal condylar screw were found on (b)(6) 2018.Revision reported under pi (b)(4).Second revision surgery was performed on (b)(6) 2018 and breakage of the all of implanted screws were found during the revision surgery.In the second revision surgery, all of the implants including the nail were replaced.
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Manufacturer Narrative
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This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
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Event Description
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It was reported that after the first revision surgery(3/9/2018), breakage of the screw which was replaced in the revision surgery and most proximal condylar screw were found on 3/19/2018.Revision reported under pi 1700980.Second revision surgery was performed on 3/30/2018 and breakage of the all of implanted screws were found during the revision surgery.In the second revision surgery, all of the implants including the nail were replaced.
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Search Alerts/Recalls
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