FDA Adverse Event
Injury
Summary report: N
LEVEL ONE CMF
MDR report key: 11854615
·
Received May 20, 2021
Report
- Report Number
- 9610905-2021-00037
- Event Type
- Injury
- Date Received
- May 20, 2021
- Date of Event
- March 17, 2021
- Report Date
- April 20, 2021
- Manufacturer
- KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
- Product Code
- MQN
- UDI-DI
- 00888118076366
- PMA / PMN Number
- K943347
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
B5 . TYPO : CHANGED SCREWS TO PLATE.
Additional Manufacturer Narrative · 0
KLS-MARTIN L.P. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG (MANUFACTURER). REFERENCE EXEMPTION NUMBER E2017029. AN INVESTIGATION WAS PERFORMED ON THE BASIS OF COMPLAINT STATISTICS AS NO DEVICE WAS RETURNED FOR EVALUATION. THE FAILURE ROOT CAUSE CANNOT BE DETERMINED DUE TO THE DEVICE NOT BEING RETURNED. 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 A PLATE BROKE DUE TO PATIENT GRINDING THEIR TEETH AND WAS REMOVED.
Description of Event or Problem · 0
IT WAS REPORTED SCREWS BROKE, POSSIBLY DUE TO THE PATIENT'S NONCOMPLIANCE, AND REQUIRED REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 755688 | LEVEL ONE CMF | PLATE | MQN | KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG | 50-407-07-09 | 00888118076366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |