Cmp-(b)(4).Concomitant medical products: 1.5mm lock plate ty-shape cat# 131220154 lot#ni, unknown screw cat#ni lot#ni, unknown screw cat#ni lot#ni.Report source: (b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: plate and screw fixation is present at the proximal first metatarsal.The plate is fractured as well as at least three of the fixation screws.The metatarsal osteotomy is displaced.The fractured screws appear loose.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, associated reports: 0001825034-2021-02736-3, 0001825034-2022-00557, 0001825034-2022-00558.
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