FDA Adverse Event
Malfunction
Summary report: N
PEDICLE SCREW 9X60MM
MDR report key: 8877723
·
Received August 9, 2019
Report
- Report Number
- 3005180920-2019-00671
- Event Type
- Malfunction
- Date Received
- August 9, 2019
- Date of Event
- June 17, 2019
- Report Date
- August 9, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- NKB
- UDI-DI
- 07630030834608
- PMA / PMN Number
- K132878
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 25 JULY 2019 LOT 143178: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2014. EXPIRATION DATE: 2019-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
TWO PEDICLE SCREWS EXPIRED HAS BEEN IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 671739 | PEDICLE SCREW 9X60MM | PEDICLE SCREW FOR SPINE IMPLANT | NKB | MEDACTA INTERNATIONAL SA | 143178 | 07630030834608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other |