FDA Adverse Event Malfunction Summary report: N

LAG SCREWDRIVER 380X110MM

MDR report key: 1892808 · Received November 3, 2010

Report

Report Number
9610622-2010-00469
Event Type
Malfunction
Date Received
November 3, 2010
Date of Event
October 14, 2010
Report Date
October 14, 2010
Manufacturer
STRYKER OSTEOSYNTHESIS KIEL
Product Code
LXH
Removal / Correction Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

IT WAS REPORTED, THE LAG SCREW DRIVER WAS NOT WORKING PROPERLY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LAG SCREWDRIVER 380X110MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA UNK

Patients

Seq Age Sex Outcome Treatment
1 86 YR Other