InjuryMBP
PLEXUR M
Received Nov 1, 2012
Report 2246640-2012-00034 · MDR key 2820107
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Nonunion/Delayed-union Bone Fracture
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A SURGEON USED RESORBABLE ALLOGRAFT BONE VOID FILLER DURING A WRIST SURGERY OF UNDETERMINED TYPE, AND THE GRAFT ALLEGEDLY "FAILED." NO ADDITIONAL PT OR DEVICE INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
(B)(4). WITHOUT ADDITIONAL DEVICE INFORMATION, NO REVIEW OF THE DEVICE HISTORY RECORD WAS POSSIBLE, AND WE ARE UNABLE TO DETERMINE A DEFINITIVE CAUSE OF THE REPORTED EVENT.