FDA Adverse Event
Malfunction
Summary report: N
MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35
MDR report key: 7918473
·
Received September 28, 2018
Report
- Report Number
- 3005180920-2018-00738
- Event Type
- Malfunction
- Date Received
- September 28, 2018
- Date of Event
- August 31, 2018
- Report Date
- September 28, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LPH
- UDI-DI
- 07630030812408
- PMA / PMN Number
- K103721
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 25 SEPTEMBER 2018. LOT 180586: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 MARCH 2018. EXPIRATION DATE: 2022-09-24. 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, WHEN THE SURGEON HAS DRILLED THE SECOND SCREW (MEASURED ACCORDING TO PROTOCOL) AND HE HAS INSERTED IT, AS THE SCREW HEAD ENGAGED THE ACETABULAR SHELL, THE HEAD OF THE SCREW BROKE OFF, LEAVING THE THREADED PORTION OF THE SCREW IN THE ACETABULUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 758263 | MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35 | CANCELLOUS BONE SCREW, FLAT HEAD | LPH | MEDACTA INTERNATIONAL SA | 180586 | 07630030812408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |