It was reported the original implant surgery occurred on (b)(6) 2023, and in (b)(6) 2023 (event date unknown), after radiographic examination, it was reported that the fixation screws on the patient's right side of the mouth were loose.It was reported the screws and plates were subsequently explanted.Report 10 of 10 for this event.
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Post-op screw loosening was reported.The device was not returned for evaluation; however, an x-ray was provided showing loose screws in the patient's lower right jaw.Review of the device history record (dhr) and inventory review could not take place as device lot number is unknown.A two-year review of the complaint database reviewed one other complaint for this issue.That complaint was reported by the same surgeon for two different patients.Per fmea and ifu review, potential causes include improper material selection/strength, user error-improper fixation technique, and/or patient noncompliance with post-op instructions.However, based on the information received and the investigation performed, the root cause could not be determined.Related reports: 2027754-2023-00061, 2027754-2023-00062, 2027754-2023-00063, 2027754-2023-00064, 2027754-2023-00065, 2027754-2023-00066, 2027754-2023-00067, 2027754-2023-00068, 2027754-2023-00069.
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Two (2) plates and eight (8) screws were received for evaluation on 19 december 2023.Visual inspection of the returned plates and screws revealed no anomalies.The product was provided to qc inspection for evaluation against the engineering drawing, and all devices met specifications.Based on the information received and the investigation performed, the root cause could not be determined.
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