MECTALIF ANTERIOR
Report
- Report Number
- 3005180920-2025-01038
- Event Type
- Malfunction
- Date Received
- October 30, 2025
- Date of Event
- September 19, 2025
- Report Date
- December 17, 2025
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- OVD
- UDI-DI
- 07630345732309
- PMA / PMN Number
- K232123
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
FU_1. PIECE MECTALIF ANTERIOR 03.30.302 MECTALIF ANT - LAG PLATE FLUSH H14 MM LOT: 2459912 RETURNED ON 18 NOVEMBER 2025. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: DURING AN ALIF SURGERY, SEVERAL INSTRUMENTS FAILED, AND THE CENTRAL SCREW OF THE ANTIBACKOUT COVER PLATE FRACTURED. SPECIFICALLY, THE TIP OF THE ANGLED AWL (REF. 03.30.10.2310) BROKE DURING USE; THE THREAD OF THE INSERTER INNER SHAFT (REF. 03.30.10.2510) WAS DAMAGED; AND THE TIPS OF TWO ANGLED SCREWDRIVERS (REF. 03.30.10.2130, LOT NO: 1954796) WERE BENT OR FRACTURED. BASED ON THE DESCRIPTION OF THE EVENT (THE PARTS ARE NOT AVAILABLE FOR VISUAL INSPECTION) AND THE INFORMATION PROVIDED, IT CAN BE HYPOTHESIZED THAT THE TIPS OF THE AWL AND THE SCREWDRIVERS FAILED DUE TO THE PATIENT'S SCLEROTIC BONE. NO INFORMATION IS AVAILABLE FOR REF. 03.30.10.2510; THEREFORE, THE ROOT CAUSE OF ITS FAILURE CANNOT BE IDENTIFIED. REGARDING THE ANTIBACKOUT COVER PLATE SCREW, THE FRACTURED PART WAS ANALYZED. BASED ON THE FRACTURE MORPHOLOGY, IT CAN BE HYPOTHESIZED THAT THE SCREW BROKE DUE TO EXCESSIVE TORSION. NO ADDITIONAL INFORMATION IS AVAILABLE TO CLEARLY IDENTIFY THE ROOT CAUSE OF THE BREAKAGE. CONCLUSION: ALTHOUGH IT CANNOT BE CONFIRMED WITH CERTAINTY, THE MOST LIKELY ROOT CAUSE OF THE ANTI-BACKOUT SCREW BREAKAGE IS THE APPLICATION OF EXCESSIVE TORSIONAL FORCE. THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE. WITH RESPECT TO THE ISSUES ON THE INSTRUMENTS, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED BASED ON THE INFORMATION CURRENTLY AVAILABLE.
BATCH REVIEW PERFORMED ON 22 OCT 2025 LOT 2459912: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEPT-2024. EXPIRATION DATE: 2029-AUG-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: MECTALIF 03.30.10.2130 ALIF SCREWDRIVER ANGLED - INNER SHAFT LOT 1954796: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-NOV-2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, TWO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. (2 DEVICES INVOLVED IN THIS CASE) CONCLUSION NOT AVAILABLE YET.
DURING PRIMARY SPINAL SURGERY AT L4-5, THE FIXED ANGLE AWL BROKE OFF IN THE BONE, THE SURGEON PULLED IT OUT AND USED A DIFFERENT FIXED ANGLE AWL TO MAKE THE HOLE FOR THE SCREW. SURGICAL STEPS PERFORMED: DISCECTOMY, TRIAL, MECTALIF IMPLANT, AWL FOR SCREW HOLES, SCREWS INSERTION AND THE COVER PLATE PLACEMENT. NO TAPPING/DRILLING PERFORMED. DURING CAUDAL SCREW INSERTION, THE SCREWDRIVER BROKE, AND A BACKUP SCREWDRIVER WAS REQUIRED. ADDITIONALLY, WHILE ATTACHING THE ANTI-BACKOUT LAG PLATE, THE ANTI-BACKOUT SCREW ON THE COVER PLATE BROKE OFF WHEN BEING TIGHTENED BY THE TORQUE LIMITER. IT WAS NOTED THAT THE BONE WAS SCLEROTIC, AND THE SURGEON DETERMINED THERE WAS NO RISK OF SCREW BACKOUT. THE BROKEN PORTION OF THE SCREW REMAINED IN THE ANTERIOR PLATE, PREVENTING THE PLACEMENT OF ANOTHER COVER PLATE. THE SURGERY WAS COMPLETED WITHOUT THE COVER PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1619002 | MECTALIF ANTERIOR | MECTALIF ANT - LAG PLATE FLUSH H14 MM | OVD | MEDACTA INTERNATIONAL SA | 03.30.302 | 2459912 | 07630345732309 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |