OSSIO LTD. OSSIOFIBER HAMMERTOE FIXATION SYSTEM, S, 2.5 X 16 MM, STRAIGHT; FIXATION, PIN, SMOOTH
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Model Number OF20025160 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Unspecified Musculoskeletal problem (4535)
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Event Date 04/26/2022 |
Event Type
Injury
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Manufacturer Narrative
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Company was notified of a revision surgery.An investigation was performed including internal analysis of records and the surgeon's feedback.The device could not be examined as it was not provided to the company.No immediate post-operative imaging was provided.No information on clinical symptoms was shared.There is no indication of a design, manufacturing or process issue affecting implant safety or effectiveness.It was noted that the implant broke, but it is unknown whether the implant was found broken or broke during the removal surgery.Two additional implants of the same size were implanted in 2 other toes during the initial procedure, with no issue reported.The root cause of the revision surgery could not be determined but is likely linked to inadequate bone fixation at time of surgery or inappropriate post operative care (i.E., additional immobilization) which may lead to unstable fixation and result in revision surgery.However, as a revision surgery was performed and because the company cannot rule out the possible contribution of the device to the event, out of an abundance of caution, this event is being reported.Company continues to monitor these events as part of post market activities.Additional report from the initial importer relating to this event is: #3014323288-2022-00006.
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Event Description
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Hammertoe revision surgery, 3rd toe, 4 months post-op.
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Search Alerts/Recalls
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