FDA Adverse Event
Malfunction
Summary report: Y
AUTOPLEX SYSTEM W/ VERTAPLEX HVV
MDR report key: 16261893
·
Received January 29, 2023
Report
- Report Number
- 3015967359-2023-00180
- Event Type
- Malfunction
- Date Received
- January 29, 2023
- Date of Event
- December 31, 2022
- Report Date
- January 29, 2023
- Manufacturer
- STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
- Product Code
- JDZ
- UDI-DI
- 37613252039250
- 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 NOT AVAILABLE FOR EVALUATION. 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 HAD DEBRIS IN STERILE PACKAGE. -1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2672 | AUTOPLEX SYSTEM W/ VERTAPLEX HVV | MIXER, CEMENT, FOR CLINICAL USE | JDZ | STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP | VMSR | 37613252039250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |