FDA Adverse Event
Injury
Summary report: N
LEVEL ONE NEURO
MDR report key: 11591057
·
Received March 30, 2021
Report
- Report Number
- 9610905-2021-00020
- Event Type
- Injury
- Date Received
- March 30, 2021
- Date of Event
- March 8, 2021
- Report Date
- March 8, 2021
- Manufacturer
- KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
- Product Code
- HRS
- UDI-DI
- 00888118048776
- PMA / PMN Number
- K971297
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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 · 1
IT WAS REPORTED THE SCREWS BECAME LOOSE AND WERE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 484877 | LEVEL ONE NEURO | SCREW | HRS | KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG | 25-975-04-91 | UNKNOWN | 00888118048776 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |