FDA Adverse Event
Malfunction
Summary report: N
LEVEL ONE THORACIC
MDR report key: 8063798
·
Received November 13, 2018
Report
- Report Number
- 9610905-2018-00292
- Event Type
- Malfunction
- Date Received
- November 13, 2018
- Report Date
- October 17, 2018
- Manufacturer
- KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
- Product Code
- HRS
- PMA / PMN Number
- K153482
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PHYSICIAN
Narratives
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.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN X-RAY SHOWED BROKEN PLATES. THERE ARE NO PLANS TO REMOVE THEM.
Additional Manufacturer Narrative · 1
DEVICE MATERIAL NUMBER NOR LOT NUMBER WAS IDENTIFIED THEREFORE COMPLAINT RATE, REVIEW OF DEVICE HISTORY RECORDS AND RISK FILE WAS NOT POSSIBLE. THE ROOT CAUSE FOR THE FAILURE CANNOT BE DETERMINED SINCE NEITHER MATERIAL NOR LOT NUMBER WERE PROVIDED. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 905971 | LEVEL ONE THORACIC | PLATE | HRS | KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |