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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Hypersensitivity/Allergic reaction (1907); Inflammation (1932)
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Event Date 02/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Product code: ikd.Product name: cable, electrode.Concomitant medical products : item # 94-1400-04, lot 429742; a&e medical / thorecon¿ box cable plate kit (inc.Screws & cable), quantity 2.Item # unk, lot # unk; unknown 14 mm screw.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.Multiple mdr reports were filed for this event, please see associated reports: 0002242056-2023-00004, 0002242056-2023-00003, 0002242056-2023-00006.
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Event Description
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It is reported the patient was revised of a sternal construct due to abnormal tissue responses over the plate sites.The surgeon indicated the possibility of a metal allergy reaction within the tissue.At the time of the revision, the sternal healing had been achieved well.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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It is further reported through medical records that the patient had an initial coronary artery bypass graft procedure.Subsequently, the patient underwent a superficial and deep wound debridement with removal of sternal plating system and vac placement surgery due to wound dehiscence, surgeon reported possible metal allergy reaction within the tissue, approximately three (3) months post-implantation.During the procedure the bone was found to be healthy and stable.There was inflammatory tissue noted around each sternal plate.No intraoperative complications were reported.
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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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Manufacturer Narrative
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This report is being submitted to update additional information in section b4, b5, d6, g3, g6, h2, h6 and h10.
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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.A definitive root cause cannot be determined.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.This report is being submitted to update additional information in section b4, b5, d4, g3, g6, h2, h3, h4, h6 and h10.
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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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