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Model Number N/A |
Device Problem
Inaccurate Information (4051)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00526.Medical products: custom made device, part# cp756106, lot# 110360.Custom made device, part# cp756108, lot# 110390.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 two mandibular components were in mislabeled boxes.The right mandible component was in the left mandible component package, and the left mandible component was in the right mandible component package.No adverse events were 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.The complaint is non-verifiable.The warford right mandible (part# cp756106, lot# 110360) and warford left mandible (part# cp756108, lot# 110390) were not returned for investigation and therefore could not be visually evaluated.A photo was provided which showed the two labels, though it could not be verified from the photo that the implants were in the incorrect package.The dhrs for these products were reviewed; no non-conformances were found.There are no indications of manufacturing defects and there are no updates to the risk documents needed.For patient matched tmj implants (cpxxxxxx) in the previous year (from the notification date) this is the only similar complaint of a mislabeling issue.This is a patient matched product and the lot number is unique to this device.There are no additional complaints on this lot.The most likely underlying cause could not be determined.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.The following fields were updated: b4 date of this report, b5 describe event or problem, d10 device availability, g4 date received by manufacturer, g7 type of report, h2 follow up type, h3 device evaluated by manufacturer, h6 method code, h6 results code, h6 conclusions code, and h10 additional narratives/data.
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Event Description
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This follow-up report is being submitted to relay additional information.
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Search Alerts/Recalls
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