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 one unk - constructs: hand plate/screws - mini fragment.This is report 10 of 10 for (b)(4).Additional events related to this study are captured under (b)(4).
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