PLEXUR M
Received Nov 1, 2012 · Event occurred Feb 5, 2011
Report 2246640-2012-00032 · MDR key 2820035
Device
Generic name
Resorbable Bone Void Filler
Manufacturer
Osteotech, Inc.Model number
UNKNOWN - SEE H10Lot number
UNKNOWN - SEE H10
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
00056 YR · Female
- Nonunion/Delayed-union Bone Fracture
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SURGEON USED RESORBABLE ALLOGRAFT BONE VOID FILLER TO REPAIR A CALCANEAL FRACTURE, AND THE PATIENT'S FOOT "NEVER REALLY HEALED." APPROXIMATELY 12 WEEKS POST-OP, A REVISION PROCEDURE WAS PERFORMED, AND THE GRAFT MATERIAL REPORTEDLY "HAD BECOME A GRANULAR, SAND-TYPE MATERIAL AND WAS NO LONGER SOLID." IT WAS NOT INDICATED WHETHER THE GRAFT MATERIAL WAS EXPLANTED AT THAT TIME. APPROXIMATELY 15 MONTHS LATER, THE PATIENT REPORTEDLY REQUIRED AN ADDITIONAL REVISION PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
(B)(4). THIS MEDWATCH REPORT WAS COMPLETED USING THE INFORMATION PROVIDED BY THE INITIAL REPORTER/HEALTHCARE PROFESSIONAL. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFORMATION NOT HAVING BEEN PROVIDED. 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.