Model Number SUTURE ANCHOR, BIO-CORKSCREW FT |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Osteolysis (2377)
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Event Date 06/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
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Event Description
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It was reported that a patient suffered from an osteolysis after the usage of an arthrex biocomposite screw.No further information received.*** update dw 26-feb-2024: further information was provided that the first arthrex employee was made aware of this issue on 22nd june 2023.The initial surgery was performed on (b)(6) 2020 with an ar-2323bcc and ar-1927bcf.The patient returned due to pain for a mri in (b)(6) 2023.*** update dw 28-feb-2024: further information were provided that no further treatment was performed due to this issue.
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Manufacturer Narrative
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The complaint is confirmed based on the mri photo that the customer provided, which displays osteolysis around the implant.The most likely cause for the reported failure can be attributed to a patient-specific event of the immune response allograft tissue and/or a previous history of infection or arthritis of the patient that was not reported due to the patient developing osteolysis.
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Search Alerts/Recalls
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