PLEXUR M
Received Aug 20, 2009 · Event occurred Jun 20, 2009
Report 2246640-2009-00001 · MDR key 1445126
Device
Generic name
Resorbable Bone Void Filler
Manufacturer
Osteotech, Inc.Model number
UNKNOWN-REQUESTEDCatalog number
UNK
Lot number
UNKNOWN-REQUESTED
Product problems
- Insufficient Device Problem Information
Patient
15 YR
- Unspecified Infection
- Fluid Discharge
Narrative
Description of Event or Problem
PT IS A FEMALE WITH A HISTORY OF MCCUNE-ALBRIGHT SYNDROME (POLYOSTOTIC FIBROUS DYSPLASIA). IN 2009, THE PT HAD A LESION ABOVE THE RIGHT ELBOW CURETTED AND GRAFTED WITH PLEXUR M. THERE WAS NO OTHER GRAFT MATERIAL NOTED. ACCORDING TO THE SURGEON, APPROXIMATELY 4 WEEKS POST-OP, THE PT WAS FELT TO HAVE A WOUND INFECTION AND ORAL ANTIBIOTIC THERAPY WAS BEGUN. APPROXIMATELY 4 WEEKS LATER, PT UNDERWENT ANOTHER SURGICAL PROCEDURE TO REMOVE THE GRAFTED MASS AND REPLACE WITH ANTIBIOTIC IMPREGNATED CALCIUM SULFATE BEADS. THE FOLLOWING MONTH, IN A TELEPHONE CONVERSATION WITH OSTEOTECH'S MEDICAL DIRECTOR, THE PT'S ONCOLOGIC ORTHOPAEDIST, DR REPORTED THAT THE PT STILL HAD DRAINAGE AND WOULD PROBABLY REQUIRE ADDITIONAL SURGICAL INTERVENTION.
Additional Manufacturer Narrative
OSTEOTECH'S MEDICAL DIRECTOR CONTACTED DR ON 08/14/2009 TO REQUEST THE LOT NUMBER OF THE SUBJECT GRAFT, AND TO INQUIRE ABOUT THE PT'S CURRENT STATUS. TO DATE OF THIS REPORT, LOT NUMBER OF THE PLEXUR M HAS NOT BEEN IDENTIFIED. THE PRODUCT IS TERMINALLY STERILIZED WITH GAMMA IRRADIATION, POST - FINAL PACKAGING, AT A DOSAGE OF 25.0 - 35.0 KGY (2.5 - 3.5 MRADS).