FDA Adverse Event Other Summary report: N

PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, LON

MDR report key: 1120769 · Received August 15, 2008

Report

Report Number
8010177-2008-00052
Event Type
Other
Date Received
August 15, 2008
Date of Event
July 16, 2008
Report Date
August 15, 2008
Manufacturer
STRYKER OSTEOSYNTHESIS FREIBURG
Product Code
HRS
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
JA
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ON (B) (6) 2008, THE PT UNDERWENT THE SURGERY WITH MATRIX SMART LOCK PLATE AND SCREWS. TWO MOS AFTER THE SURGERY, THE SURGEON FOUND THROUGH THE X-RAY THAT THE DISTAL LOCKING SCREW WAS BROKEN. THE SURGEON USED SMART LOCK PLATE IN THE REVISION SURGERY AND THE SURGERY WAS COMPLETED WITHOUT PROBLEM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, LON IMPLANT HRS STRYKER OSTEOSYNTHESIS FREIBURG UNK

Patients

Seq Age Sex Outcome Treatment
1 60 YR Required Intervention