MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ACDF MECTA-C SA DRILL SCREW LOCK 3.8X14 (2X); ANTERIOR VERTEBRAL FIXATION SCREW

Model Number	03.18.622
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27-mar-2021: lot 1923963: (b)(4) items manufactured and released on 21-apr-2020.Expiration date: 2025-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by clinical affairs director: few days after bi-level cervical stabilization surgery, one of the plate fixation screws migrated and perforated the esophagus, which required urgent reoperation.From the postoperative images, it seems that the migrated screw never reached the final correct position, it may have been inserted at an angle that did not allow the plate's thread to be properly engaged.This was probably also due to the rather sclerotic bone.This hypothesis is also confirmed by the fact that the torque limiting device opened before the screw was finally inserted.Visual inspection performed by r&d project manager: it was observed that the beginning of the thread of the screw, below the head, is deformed.It is bent towards the head and there is a loss of anodization in the inferior part of the thread.Tests were performed on a similar screw and it was noted that it deformed (as previously described) when it was not fully seated in the plate.Following these results, in conjunction with analysis of xrays and provided picture, it is possible to hypothesize that the root cause of the complaint could be due to the not correct tightening of the migrated screw.
Event or Problem Description
3 weeks after the primary surgery the patient had severe cervical spine pain, it was recognised that one of the three plate screws was totally unscrewed.The patient was revised immediately, removing the screw.During surgery it was discovered that the esophagus was perforated.
Additional Manufacturer Narrative
Additional surgeon comment: the surgeon mentioned that 10 days post-op the patient was without complications.However, the complication started within 24 hours after the physiotherapy, that the time point where they did the 3 week post op ct scan, detected the migrated screw and performed the revision surgery.

• Brand Name: ACDF MECTA-C SA DRILL SCREW LOCK 3.8X14 (2X)
• Common Device Name: ANTERIOR VERTEBRAL FIXATION SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11594893
• Report Number: 3005180920-2021-00261
• Device Sequence Number: 11664205
• Product Code: OVE
• UDI-Device Identifier: 07630040726603
• UDI-Public: 07630040726603
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 03.18.622
• Device Catalogue Number: 03.18.622
• Device Lot Number: 1923963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2021
• Supplement Date Received by Manufacturer: 03/06/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR