BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCRW 2.4X12MM CANCELOUS LOCKNG; PLATE, FIXATION, BONE
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Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Fluid Discharge (2686)
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Event Date 03/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).D10 ¿ medical products item# 73-2643, lot# j7354048, sternalock blu plate 4 hole l 100 deg; qty 1.Item# 73-2623, lot# j7397832, sternalock blu plate 8 hole x; qty 2.Item# 73-2412, lot# unk, sternalock blu system scrw 2.4x12mm cancelous lockng; qty 11.G2: foreign source: japan.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: 0001032347-2023-00183; 0001032347-2023-00184; 0001032347-2023-00185; 0001032347-2023-00196; 0001032347-2023-00195; 0001032347-2023-00194; 0001032347-2023-00193; 0001032347-2023-00192; 0001032347-2023-00191; 0001032347-2023-00190; 001032347-2023-00189; 0001032347-2023-00188; 0001032347-2023-00187; 0001032347-2023-00186.
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Event Description
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It is reported that the patient underwent a procedure and subsequently post operative drainage was observed from the drain attached to the patient.The following day, a computed tomography scan of the treatment site showed that the plate that had been attached to the sternum, had fallen off.Also, the screws had fallen into the chest cavity.In the sternal body and talar body, all screws on the one side had fallen out and were in the chest cavity.The patient remains under observation and no further intervention is currently planned.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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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.Lot identification is necessary for review of device history records, lot identification was not provided for the screws.A definitive root cause cannot be determined.The reported event cannot be confirmed.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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