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