FDA Adverse Event
Injury
Summary report: N
LEVEL ONE CMF
MDR report key: 10983743
·
Received December 10, 2020
Report
- Report Number
- 9610905-2020-00139
- Event Type
- Injury
- Date Received
- December 10, 2020
- Date of Event
- November 24, 2020
- Report Date
- November 24, 2020
- Manufacturer
- KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
- Product Code
- MQN
- UDI-DI
- 00888118078407
- PMA / PMN Number
- K032442
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
KLS-MARTIN L.P. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF KARL LEIBINGER MEDIZINTECHNIK (B)(4) (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 · 1
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1451913 | LEVEL ONE CMF | PLATE | MQN | KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG | 50-775-26-09 | UNKNOWN | 00888118078407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |