FDA Adverse Event
Injury
Summary report: N
PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X50MM
MDR report key: 8137078
·
Received December 6, 2018
Report
- Report Number
- 3005180920-2018-00972
- Event Type
- Injury
- Date Received
- December 6, 2018
- Date of Event
- November 6, 2018
- Report Date
- December 6, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- NKB
- UDI-DI
- 07630030857775
- PMA / PMN Number
- K141988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON (B)(6) 2018; LOT 1820890: 100 ITEMS MANUFACTURED AND RELEASED ON 21 JUN 2018; EXPIRATION DATE: 2023-06-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 34 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN COMPLAINING OF PAIN AND THE SURGEON STATED HE WAS DISPLEASED WITH THE SCREW PLACEMENT. A 7X50MM SCREW WAS REMOVED AND REPLACED WITH A 6X50MM SCREW AFTER ABOUT 1 MONTH FROM THE PRIMARY. THE SURGEON DIDN'T USE THE MYSPINE GUIDES IN PRIMARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 976650 | PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X50MM | SPINE PEDICLE SCREW | NKB | MEDACTA INTERNATIONAL SA | 1820890 | 07630030857775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |