Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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Journal received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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 3 patients required fusion due to inadequate curve correction with no apparent tether breakage (revision surgery).
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Manufacturer Narrative
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Journal received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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.(b)(4).
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Event Description
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It was reported that 3 patients required fusion due to inadequate curve correction with no apparent tether breakage (revision surgery).
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.Reported event: it was reported that 3 patients required fusion due to inadequate curve correction with no apparent tether breakage (revision surgery).As no product was returned, visual and dimensional evaluations could not be performed.Review of the device history records could not be done as the lot number was not available.No further due diligence required as all required information to support the conclusion is available or was already requested.Device is used for treatment.Insufficient information provided.Unable to perform a compatibility check.Review of complaint history could not be done as the reference number was not available.Medical records were not provided.The investigation did not identify a nonconformance or a complaint out of box (coob).A definitive root cause cannot be determined.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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No change to previously reported event.
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Event Description
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No additional information at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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