The plate has broken per x-ray (b)(6) 2022, requiring replacement; surgery to be done (b)(6) 2022.One of the screws also broke.Are these items made from steel or titanium? two x-ray pictures uploaded may be of poor quality, taken (b)(6) 2022, one is from 4-week post op follow up, other is from (b)(6) 2022 follow up, per the chart, the implant is: plate 7 hole condylar 95 degree 70mm/124mm, implant type: plate implanted area: femur, laterality: left implanted on: (b)(6) 2021, number implanted:1, implanted by: (b)(6), md implanted at: (b)(6); status: implanted, manufacturer: synthes cmf (formerly maxillofacial) model number: 23774, lot number: na.All 7 self tapping screws (only one broken) are also synthes, models 214.Xxx (last three numbers vary with screw size).Fda safety report id# (b)(4).
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