FDA Adverse Event Malfunction Summary report: N

RADIONICS NON-DISPOSABLE HEAD RING SCREWS (LONG)

MDR report key: 609861 · Received July 8, 2004

Report

Report Number
1222895-2004-00004
Event Type
Malfunction
Date Received
July 8, 2004
Report Date
June 9, 2004
Manufacturer
RADIONICS
Product Code
HBL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE USER WAS AFFIXING THE BRW HEAD RING TO THE PT'S HEAD AND THE HEAD RING SCREW BROKE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 RADIONICS NON-DISPOSABLE HEAD RING SCREWS (LONG) NON-DISPOSABLE HEAD RING SCREWS (LONG) HBL RADIONICS HRS (L) UNK

Patients

Seq Age Sex Outcome Treatment
1 NO INFO Other