FDA Adverse Event
Malfunction
Summary report: N
AVALIGN
MDR report key: 20863290
·
Received December 6, 2024
Report
- Report Number
- 1421101-2024-00006
- Event Type
- Malfunction
- Date Received
- December 6, 2024
- Date of Event
- November 4, 2024
- Report Date
- December 3, 2024
- Manufacturer
- AVALIGN TECHNOLOGIES INC.
- Product Code
- GZX
- UDI-DI
- 00190776068103
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
ON 11/06/2024, AVALIGN GSI QUALITY RECEIVED A CUSTOMER COMPLAINT FROM STERIS CORPORATION. STERIS CORP REPORTED THAT THEIR CUSTOMER, THE NEBRASKA MEDICAL CENTER,REPORTED TO THEM THAT THEY HAD TWO (2) UNITS OF CUSTOMER PART# VM82-7222 THAT THE BALL TIPS BROKE OFF DURING A CASE. THEY WERE REMOVED WITH NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2095408 | AVALIGN | KRAY HOOK WITH FINGER RET LARGE BALL TIP TIP 3.5MM OL 185 (7 1/4") | GZX | AVALIGN TECHNOLOGIES INC. | VM82-7222 | 04012 | 00190776068103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |