Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant product(s): part #:906063 lot:# 71635.Part #:906063 lot:# 71569.Part #:906063 lot:# 71624.Report source: foreign: (b)(6) customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-08284, 0001825034-2017-08285, 0001825034-2017-08288.
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Event Description
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It was reported that during an unknown procedure, four devices created unknown problems.No adverse events have been reported as a result of the malfunction.Attempts have been made to gather information but no further information has been provided.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0001825034-2017-09701.The following sections were {updated/corrected}.
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Search Alerts/Recalls
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