FDA Adverse Event
Injury
Summary report: N
PEDICLE SCREW MUST MC SCREW Ø6X40 REDUCTION CANN.
MDR report key: 14012348
·
Received April 5, 2022
Report
- Report Number
- 3005180920-2022-00223
- Event Type
- Injury
- Date Received
- April 5, 2022
- Date of Event
- March 3, 2022
- Report Date
- April 5, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- NKB
- UDI-DI
- 07630971296169
- PMA / PMN Number
- K210427
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 08 MARCH 2022. LOT 2120121: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-OCT-2021. EXPIRATION DATE: 2026-SEP-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
AT ABOUT 1 MONTH AND A HALF AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE L5 SCREW THAT OCCURRED FROM EXERCISING. THE SURGEON REVISED THE SCREW AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 94611 | PEDICLE SCREW MUST MC SCREW Ø6X40 REDUCTION CANN. | SPINE PEDICLE SCREW | NKB | MEDACTA INTERNATIONAL SA | 03.58.644 | 2120121 | 07630971296169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |