FDA Adverse Event
Malfunction
Summary report: N
ROUND HEAD INTERFERENCE SCREW LIGAFIX 30 Ø 9 MM - LG 25 MM
MDR report key: 8598532
·
Received May 10, 2019
Report
- Report Number
- 3004549189-2019-00047
- Event Type
- Malfunction
- Date Received
- May 10, 2019
- Report Date
- March 28, 2019
- Manufacturer
- S.B.M. SAS
- Product Code
- MAI
- PMA / PMN Number
- K122228
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. THIS BATCH OF SCREWS PRESENTS NO MANUFACTURING DEFECT. EVERYTHING CONFORMS TO SPECIFICATIONS. IN THE ABSENCE OF ADDITIONAL INFORMATION AND IN THE IMPOSSIBILITY OF RECOVERING THE SCREW FOR EXPERTISE, THE CAUSE OF THIS BREAKAGE IS NOT DETERMINABLE.
Description of Event or Problem · 1
FNC (B)(4) - FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. HEALTH FACILITY ASKED FOR SCREW TO BE REPLACED DUE TO IMPLANTATION FAILURE : SCREW BROKE AND WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 393214 | ROUND HEAD INTERFERENCE SCREW LIGAFIX 30 Ø 9 MM - LG 25 MM | INTERFERENCE SCREW | MAI | S.B.M. SAS | 152135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |