FDA Adverse Event
Injury
Summary report: N
ACDF STAND ALONE CERVICAL
MDR report key: 23864344
·
Received December 22, 2025
Report
- Report Number
- 3005180920-2025-01301
- Event Type
- Injury
- Date Received
- December 22, 2025
- Date of Event
- December 8, 2025
- Report Date
- December 22, 2025
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- OVE
- UDI-DI
- 07630040726603
- PMA / PMN Number
- K192906
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 12 DECEMBER 2025. ACDF 03.18.622 MECTA-C SA DRILL SCREW LOCK Ø3.8X14 (2X) LOT. 2328162 (K192906) LOT 2328162: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-NOV-2023. EXPIRATION DATE: 2028-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 71 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: IT IS POSSIBLE THAT VARIABLES UNIQUE TO THE SPECIFIC SURGICAL APPLICATION INVOLVED MAY HAVE RESULTED IN THE ISSUE, HOWEVER NO CONFIRMATION CAN BE MADE BASED ON THE EVALUATION. THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE.
Description of Event or Problem · 0
REVISION SURGERY 9 MONTHS AFTER THE PRIMARY DUE TO MECTA C SA PLATE FIXATION SCREW LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2256898 | ACDF STAND ALONE CERVICAL | MECTA-C SA DRILL SCREW LOCK Ø3.8X14 (2X) | OVE | MEDACTA INTERNATIONAL SA | 03.18.622 | 2328162 | 07630040726603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Required Intervention |