Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a procedure during which the surgeon implanted two (2) bars with out stabilizers.The surgeon crossed the bars and placed a medial stitch along with lateral stitches to stabilize the bars.One of the bars flipped post operatively and the patient was revised subsequently without the removal of the implant.No harm is reported to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Medical products: item# 78-6130, lot# 087400, pectus blu prbnt ti bar 13in.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00217.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.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to off label usage of the product.Surgeon implanted 2 bars and intentionally crossed the bars, no stabilizers were implanted.Surgeon knows the bars were implanted with off label use and does not feel the implants failed or had anything to do with bar flipping.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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Event Description
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No further event information is available at the time of this report.
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Search Alerts/Recalls
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