FDA Adverse Event
Malfunction
Summary report: N
SMALL UP-ANGLED CURETTE
MDR report key: 17682864
·
Received September 1, 2023
Report
- Report Number
- MW5145141
- Event Type
- Malfunction
- Date Received
- September 1, 2023
- Date of Event
- August 23, 2023
- Report Date
- August 28, 2023
- Manufacturer
- NUVASIVE, INC.
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- KY, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
NUVASIVE ANGLED CURETTE- 6900314- MALFUNCTIONED DURING PROCEDURE, TIP BROKE WHILE USING DURING THE PROCEDURE AND WAS RECOVERED BY MD- NO OTHER ISSUES NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1870022 | SMALL UP-ANGLED CURETTE | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | NUVASIVE, INC. | 6900314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |