FDA Adverse Event
Malfunction
Summary report: N
AWL; SIZE 20 MM
MDR report key: 16898775
·
Received May 9, 2023
Report
- Report Number
- 3004774118-2023-00055
- Event Type
- Malfunction
- Date Received
- May 9, 2023
- Date of Event
- March 28, 2023
- Report Date
- August 1, 2023
- Manufacturer
- K2M, INC.
- Product Code
- LXH
- UDI-DI
- 10888857025530
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H6 CODING HAS BEEN UPDATED TO REFLECT COMPLETION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE LOCATION UNKNOWN.
Description of Event or Problem · 0
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A CHESAPEAKE AL AWL FRACTURED OFF INTRA-OPERATIVELY, AND THAT THE TIP REMAINED IN THE IMPLANTED CAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Description of Event or Problem · 0
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A CHESAPEAKE AL AWL FRACTURED OFF INTRA-OPERATIVELY, AND THAT THE TIP REMAINED IN THE IMPLANTED CAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 688559 | AWL; SIZE 20 MM | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | K2M, INC. | 2008-90028 | CNFV | 10888857025530 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |