FDA Adverse Event
Injury
Summary report: N
MILLENNIUM
MDR report key: 25209094
·
Received May 18, 2026
Report
- Report Number
- MW5188364
- Event Type
- Injury
- Date Received
- May 18, 2026
- Date of Event
- May 12, 2026
- Report Date
- May 13, 2026
- Manufacturer
- AVALIGN TECHNOLOGIES, INC.
- Product Code
- GEN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DURING THE LEFT TOTAL HIP ARTHROPLASTY PROCEDURE, A BONE CLAMP BROKE. ALL PIECES CONFIRMED TO BE PRESENT BY STERILE PROCESSING DEPARTMENT PERSONNEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 457086 | MILLENNIUM | FORCEPS, GENERAL & PLASTIC SURGERY | GEN | AVALIGN TECHNOLOGIES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male | Required Intervention |