This event has been recorded by zimmer biomet under (b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-00631, 0001526350-2023-00837, 0001526350-2023-00839, 0001526350-2023-00841 once the investigation is complete, a follow up/final report will be submitted.H3 other text : unknown dermatome.
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This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Lot/serial identification is necessary for review of device history records, and lot/serial identification was not provided.A definitive root cause cannot be determined.The event cannot be confirmed.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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