Additional information was received on 22 december 2023 regarding the patient and the reported event.It was reported the original implant surgery was on (b)(6) 2023, and 12 days after surgery (event date 17 october 2023), a radiographic examination was performed where it was confirmed that the fixed plates were broken.On (b)(6) 2023, a new surgery was performed, where the material was explanted, and a new material was implanted again.
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The devices were received on 19 december 2023 for evaluation.Review of the dhrs revealed no anomalies.Additionally, review of material composition of the devices as well as manufacturing processes indicated no changes to either since release of these products.As received, the four (4) plates were fractured, and visual inspection revealed some warping on the plates.It is unknown if this warping occurred due to the reported event, during the initial implant surgery, or due to explant damage.Visual inspection of the returned screws revealed no anomalies.The returned parts were given to qc inspection for evaluation against the engineering drawings, and all devices met specifications.A two-year review of the complaint database for the 211-20xx part family revealed only one (1) complaint for post-op plate breakage- which is the complaint within this report.Similarly, review of the complaint database for part number: 210-0030 revealed one (1) complaint for post-op plate breakage (which is the complaint in this report).Potential causes for post-op plate breakage include improper material selection/strength, user error-improper fixation technique, patient noncompliance with post-op instructions, excessive bending while contouring plates, improper plate size selection, and no/slow osteogenesis, osteolysis, bone resorption.However, based on the information received and the investigation performed, the root cause could not be determined.Original report was submitted: report number 2027754-2023-00054.Based on the additional information received on 22 december 2023, it was reported additional devices were involved, therefore, the following related reports have been submitted: 2027754-2024-00002, 2027754-2024-00003, 2027754-2024-00004, 2027754-2024-00005, 2027754-2024-00006, 2027754-2024-00007, 2027754-2024-00008, 2027754-2024-00009, 2027754-2024-00010, 2027754-2024-00011, 2027754-2024-00012, 2027754-2024-00013, 2027754-2024-00014, 2027754-2024-00015, 2027754-2024-00016, 2027754-2024-00017, 2027754-2024-00018, and 2027754-2024-00020.
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