FDA Adverse Event
Injury
Summary report: N
LEVEL ONE CMF
MDR report key: 19670596
·
Received July 3, 2024
Report
- Report Number
- 9610905-2024-00050
- Event Type
- Injury
- Date Received
- July 3, 2024
- Date of Event
- June 4, 2024
- Report Date
- May 27, 2025
- Manufacturer
- KLS MARTIN SE & CO. KG
- Product Code
- JEY
- UDI-DI
- 00888118046734
- PMA / PMN Number
- K943347
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
AN INVESTIGATION WAS SUCCESSFULLY COMPLETED. THE RESULTS OF THE INVESTIGATION HAVE IDENTIFIED NO MANUFACTURING ISSUES, NO DESIGN ISSUES AND/OR CORRECTIVE ACTIONS NECESSARY AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT NON-LOCKING FIXATION SCREWS IMPLANTED IN A MANDIBLE HAD BECOME LOOSENED FROM COMPROMISED BONE 17 MONTHS AFTER IMPLANTATION. THEY WERE REMOVED, DISCARDED, AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 959491 | LEVEL ONE CMF | SCREW | JEY | KLS MARTIN SE & CO. KG | 25-872-07-91 | 33510813 | 00888118046734 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |