Model Number N/A |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis as it was implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source ¿ (b)(6).
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Event Description
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It was reported the custom cranioplasty plate was too small and did not fit as desired.The surgeon had to use bone cement in the caudal area of the defect in order to completely repair the defect.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Photos of the defect were provided, which appears to show a gap in between the implant and the patient's skull.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The investigation from the manufacturer noted that there were no design/manufacturing process issues that would have contributed to this complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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