DRIVER; SIZE 10
Report
- Report Number
- 3004774118-2022-00270
- Event Type
- Malfunction
- Date Received
- July 12, 2022
- Date of Event
- June 13, 2022
- Report Date
- October 5, 2022
- Manufacturer
- K2M, INC.
- Product Code
- LXH
- UDI-DI
- 10888857029873
- PMA / PMN Number
- K111835
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
D2A, COMMON DEVICE NAME, WAS CORRECTED FROM "INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL" TO "ORTHOPEDIC MANUAL SURGICAL INSTRUMENT". G4, PMA/510(K) OR BLA #, WAS CORRECTED FROM "K111835" TO "BLANK" . H6 CODING HAS BEEN UPDATED TO REFLECT INVESTIGATION CONCLUSION. H3 OTHER TEXT : NO PRODUCT RETURNED.
A COMPANY REPRESENTATIVE REPORTED THAT FOUR PYRENEES CONSTRAINED CERVICAL DRIVERS WERE NOT HOLDING SCREWS AND ONE PYRENEES CONSTRAINED CERVICAL TORQUE LIMITING DRIVER DID NOT FIT PROPERLY IN HANDLE INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE THIRD OF THE FIVE DRIVERS.
A COMPANY REPRESENTATIVE REPORTED THAT FOUR PYRENEES CONSTRAINED CERVICAL DRIVERS WERE NOT HOLDING SCREWS AND ONE PYRENEES CONSTRAINED CERVICAL TORQUE LIMITING DRIVER DID NOT FIT PROPERLY IN HANDLE INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE THIRD OF THE FIVE DRIVERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 772799 | DRIVER; SIZE 10 | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | K2M, INC. | 201-90030 | UNKNOWN | 10888857029873 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |