Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Information (3190)
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Event Date 02/03/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been implanted.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
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Event Description
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It was reported that during a femoral plating procedure, the cable holes in the plate were too small to allow the cable to pass.The plate was already fixed to the patient with screws and the surgeon did not want to remove it so he used cerclage wires to complete the procedure.There was a 1 -2 hour delay in the procedure reported.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Concomitant products:: 1.8mm stainless steel bone plate cable, 914mm, item #: 002232-003-018, lot #: ni.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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