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, 0001526350-2023-00835, 0001526350-2023-00837, 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).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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