Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 10/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The manufacturer did not receive x-rays, or other source documents for review.The lot number of the device was received.The device history records will be reviewed during investigation.An e-mail requesting additional information was sent to the appropriate representatives.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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It was reported that during surgery the dynesys pedicile screw failed.No other information is available at the moment.Additional information has to be requested.
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Event Description
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Please refer to report 0009613350-2019-00672.
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Manufacturer Narrative
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Harm: s1 - no patient, user, or other stakeholder harm (assumed).Hazard: unknown event.No event description or relevant medical data has been received.Product has not been returned.The product is intended for treatment.The investigation results did not identify a non-conformance or a complaint out of box (coob).Based on the significant lack of information, no failure mode could be identified and no root cause could be found.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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Search Alerts/Recalls
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