FDA Adverse Event
Malfunction
Summary report: Y
11G CURETTE
MDR report key: 21201028
·
Received January 21, 2025
Report
- Report Number
- 3015967359-2025-00220
- Event Type
- Malfunction
- Date Received
- January 21, 2025
- Date of Event
- December 31, 2024
- Report Date
- January 21, 2025
- Manufacturer
- STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
- Product Code
- OCJ
- UDI-DI
- 07613252639794
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS 1 DEVICE WAS RECEIVED. ADDITIONAL INFORMATION 1 DEVICE WAS LABELED FOR SINGLE-USE. 1 DEVICE WAS NOT REPROCESSED OR REUSED.
Description of Event or Problem · 0
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 708763 | 11G CURETTE | SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY | OCJ | STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP | VMSR | 07613252639794 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |