This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra): evaluation of healthcare outcomes of patients treated with depuy synthes upper extremity plate systems identified in the phd between 2000 and 2023.Complications have been identified as per icd 9 & 10 categorization experienced by the following with corresponding intervention, per plate system: clavicle plates: 4 patients had infection, during index admission.26 patients had mechanical complication, during index admission.13 patients had other complication, during index admission.202 patients had subsequent surgery, 0-3 months post-index.55 patients had nonunion/ malunion, 0-3 months post-index.50 patients had infection, 0-3 months post-index.66 patients had mechanical complication, 0-3 months post-index.109 patients had other complication, 0-3 moths post-index.491 patients had subsequent surgery, 0-12 months post-index.86 patients had had nonunion/ malunion, 0-12 months post-index.54 patients had infection, 0-12 months post-index.79 patients had mechanical complication, 0-12 months post-index.277 patients had other complication, 0-12 months post-index.Proximal humerus plates: 20 patients had infection, during index admission.43 patients had mechanical complication, during index admission.55 patients had other complication, during index admission.452 patients had subsequent surgery, 0-3 months post-index.148 patients had nonunion/ malunion, 0-3 months post-index.160 patients had infection, 0-3 months post-index.221 patients had mechanical complication, 0-3 months post-index.224 patients had other complication, 0-3 months post-index.939 patients had subsequent surgery, 0-12 months post-index.307 patients had nonunion/ malunion, 0-12 months post-index.212 patients had infection, 0-12 months post-index.290 patients had mechanical complication, 0-12 months post-index.417 patients had other complication, 0-12 months post-index.Elbow plates (combined with lcp hook plates): 20 patients had infection, during index admission.57 patients mechanical complication, during index admission.41 patients had other complication, during index admission.433 patients had subsequent surgery, 0-3 months post-index.102 patients had nonunion/ malunion, 0-3 months post-index.191 patients had infection, 0-3 months post-index.150 patients had mechanical complication, 0-3 months post-index.231 patients had other complication, 0-3 months post-index.879 patients had subsequent surgery, 0-12 months post-index.212 patients had nonunion/ malunion, 0-12 months post-index.246 patients had infection, 0-12 months post-index.196 patients had mechanical complication, 0-12 months post-index.457 patients had other complication, 0-12 months post-index.Ulna osteotomy plates: 1 patient had other complication, during index admission.1 patient had nonunion/ malunion, 0-3 months post-index.1 patient had other complication, 0-3 months post-index.6 patients had subsequent surgery, 0-12 months post-index.3 patients had nonunion/ malunion, 0-12 months post-index.4 patients had other complication, 0-12 months post-index.Distal ulna plates: 5 patients had mechanical complication, during index admission.3 patients had other complication, during index admission.26 patients had subsequent surgery, 0-3 months post-index.8 patients had nonunion/ malunion, 0-3 months post-index.6 patients had infection, 0-3 months post-index.5 patients had mechanical complication, 0-3 months post-index.10 patients had other complication, 0-3 months post-index.49 patients had subsequent surgery, 0-12 months post-index.10 patients had nonunion/ malunion, 0-12 months post-index.8 patients had infection, 0-12 months post-index.6 patients had mechanical complication, 0-12 months post-index.26 patients had other complication, 0-12 months post-index.Distal radius plates: 13 patients had infection, during index admission.26 patients had mechanical complication, during index admission.32 patients had other complication, during index admission.284 patients had subsequent surgery, 0-3 months post-index.80 patients had nonunion/ malunion, 0-3 months post-index.91 patients had infection, 0-3 months post-index.70 patients had mechanical complication, 0-3 months post-index.133 patients had other complication, 0-3 months post-index.719 patients had subsequent surgery, 0-12 months post-index.147 patients had nonunion/ malunion, 0-12 months post-index.116 patients had infection, 0-12 months post-index.94 patients had mechanical complication, 0-12 months post-index.348 patients had other complication, 0-12 months post-index.Lcp wrist fusion plates: 1 patient had infection, during index admission.28 patients had mechanical complication, during index admission.35 patients had other complication, during index admission.27 patients had subsequent surgery, 0-3 months post-index.7 patients had nonunion/ malunion, 0-3 months post-index.12 patients had infection, 0-3 months post-index.35 patients had mechanical complication, 0-3 months post-index.47 patients had other complication, 0-3 months post-index.140 patients had subsequent surgery, 0-12 months post-index.14 patients had nonunion/ malunion, 0-12 months post-index.19 patients had infection, 0-12 months post-index.50 patients had mechanical complication, 0-12 months post-index.79 patients had other complication, 0-12 months post-index.Hand and foot plates - hand plates: 2 patients had infection, during index admission.6 patients had mechanical complication, during index admission.7 patients had other complication, during index admission.61 patients had subsequent surgery, 0-3 months post-index.13 patients had nonunion/ malunion, 0-3 months post-index.16 patients had infection, 0-3 months post-index.11 patients had mechanical complication, 0-3 months post-index.27 patients had other complication, 0-3 months post-index.140 patients had subsequent surgery, 0-12 months post-index.29 patients had nonunion/ malunion, 0-12 months post-index.23 patients had infection, 0-12 months post-index.20 patients had mechanical complication, 0-12 months post-index.64 patients had other complication, 0-12 months post-index.Hand and food plates - mini fragment plates: 14 patients had infection, during index admission.15 patients had mechanical complication, during index admission.19 patients had other complication, during index admission.136 patients had subsequent surgery, 0-3 months post-index.54 patients had nonunion/ malunion, 0-3 months post-index.66 patients had infection, 0-3 months post-index.30 patients had mechanical complication, 0-3 months post-index.69 patients had other complication, 0-3 months post-index.383 patients had subsequent surgery, 0-12 months post-index.120 patients had nonunion/ malunion, 0-12 months post-index.88 patients had infection, 0-12 months post-index.51 patients had mechanical complication, 0-12 months post-index.161 patients had other complication, 0-12 months post-index.This report involves unk - constructs: 2.0 mm locking distal ulna plate/screws.This is report 3 of 7 for (b)(4).Additional reports related to this study are captured under (b)(4).
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