PLEXUR M,
Received Oct 17, 2012 · Event occurred Jan 1, 2010
Report 2246640-2012-00031 · MDR key 2799617
Device
Generic name
Resorbable Bone Void Filler
Manufacturer
Osteotech, Inc.Catalog number
6100-010
Lot number
OTXCT0101017
Product problems
- Extrusion
Patient
Not reported
- Wound Dehiscence
- Impaired Healing
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SURGEON USED RESORBABLE ALLOGRAFT BONE VOID FILLER TO FILL A BENIGN CORTICAL BONE CYST IN THE PT'S TIBIA. THE PRODUCT WAS REPORTEDLY IMPLANTED IN A "RATHER SUPERFICIAL LOCATION." AFTER AN UNREPORTED PERIOD OF TIME, GRANULES WERE ESCAPING FROM THE WOUND, AND THE PT EXPERIENCED DELAYED WOUND HEALING. THE SURGEON REMOVED GRANULAR MATERIAL FROM THE SUTURE SITE, FLUSHED AND THE SITE AND RECLOSED THE WOUND.
Additional Manufacturer Narrative
(B)(6). (B)(4). THE MANUFACTURING RECORDS FOR THE SUBJECT LOT OF PRODUCT WERE REVIEWED AND INDICATED THAT THE PRODUCT WAS MANUFACTURED PER PROCEDURE AND MET ALL REQUIRED SPECIATIONS. THERE WERE NO IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH THE MANUFACTURING OF THIS PRODUCT. THERE HAVE BEEN NO ADDITIONAL REPORTS OF THIS NATURE INVOLVING ANY OTHER PRODUCT MANUFACTURED IN THE LOT.