FDA Adverse Event
Malfunction
Summary report: N
MECTALIF ANTERIOR MECTALIF ANTERIOR STAND-ALONE PLATE LONG H.14 MM
MDR report key: 8595278
·
Received May 9, 2019
Report
- Report Number
- 3005180920-2019-00365
- Event Type
- Malfunction
- Date Received
- May 9, 2019
- Date of Event
- April 8, 2019
- Report Date
- May 9, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- OVD
- UDI-DI
- 07630030833618
- PMA / PMN Number
- K124034
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 06 MAY 2019: LOT 143316: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-APR-2015. EXPIRATION DATE: 2020-02-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
DURING SURGERY THE FINAL SCREW FAILED TO LOCK IN THE PLATE. IT JUST KEPT TURNING IN THE PLATE AND BONE. THE SURGEON TRIED A RESCUE SCREW AND SAME RESULT. THE SURGEON DID NOT WANT TO REMOVE THE PLATE AND LEFT WITH 3 SCREWS ONLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 387663 | MECTALIF ANTERIOR MECTALIF ANTERIOR STAND-ALONE PLATE LONG H.14 MM | SPINE ANTERIOR STAND-ALONE INTERVERTEBRAL PLATE | OVD | MEDACTA INTERNATIONAL SA | 143316 | 07630030833618 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |