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Model Number N/A |
Device Problem
Unexpected Therapeutic Results (1631)
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Patient Problems
Impaired Healing (2378); Skin Tears (2516); Swelling/ Edema (4577)
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Event Date 04/27/2022 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It is reported that the patient was revised due to plate exposure while suffering from sinusitis.The patient is not infected, and the size of the exposure was about 1.5 cm x 1.5 cm.The wound was left open to assist in treatment of the sinusitis.The patient is scheduled to have the exposed area closed at a later date.Attempts have been made and no further information has been provided.
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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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Event Description
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It has been further reported that the patient has not been revised of the implant to date.
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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 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 records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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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Search Alerts/Recalls
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