FDA Adverse Event
Injury
Summary report: N
LEVEL ONE CMF
MDR report key: 24915725
·
Received April 17, 2026
Report
- Report Number
- 1000525271-2026-00007
- Event Type
- Injury
- Date Received
- April 17, 2026
- Date of Event
- March 20, 2026
- Report Date
- May 20, 2026
- Manufacturer
- KLS-MARTIN L.P.
- Product Code
- JEY
- PMA / PMN Number
- K944565
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PLATES IDENTIFIED: 25-308-06-09, 25-308-87-09 , 25-308-09-09. LOTS IDENTIFIED: 211716, 233826, 211916.
Description of Event or Problem · 0
IT WAS REPORTED THAT PLATES WERE IDENTIFIED AS FRACTURED ON IMAGING FOLLOWING APPROXIMATELY FOUR AND HALF YEARS OF IMPLANTATION. THEY WERE REMOVED AND NOT REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222184 | LEVEL ONE CMF | PLATE | JEY | KLS-MARTIN L.P. | SEE H11 | SEE H11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Female | Other |