GRAFTON DBM MATRIX PLF
Received Nov 19, 2013 · Event occurred Oct 8, 2013
Report 2246640-2013-00026 · MDR key 3477547
Device
Generic name
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Manufacturer
Osteotech, Inc (subsidiary Of Medtronic)Model number
T42210Catalog number
T42210
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
00046 YR
- Pain
- Seroma
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT RECEIVED ALLOGRAFT BONE VOID FILLER DURING A LUMBAR FUSION (L4 - L5). APPROXIMATELY ONE WEEK LATER, DUE TO "INCREASED BACK AND LEG PAIN" AFTER SURGERY, AND "FLUID COLLECTION (SEROMA) ON MRI," THE PATIENT WAS TAKEN BACK INTO SURGERY FOR I & D. THERE WAS NO REPORT OF INFECTION. AT THE TIME OF THIS REPORT THE PATIENT WAS "DOING GREAT," AND IT WAS REPORTED THAT THE SURGEON DID NOT SEEM TO THINK THIS INCIDENT WAS DUE TO THE ALLOGRAFT IMPLANT.
Additional Manufacturer Narrative
(B)(6). (B)(4). THE MANUFACTURING RECORDS FOR THE LOT OF PRODUCT WERE REVIEWED, AND INDICATED THAT THE GRAFT WAS MANUFACTURED ACCORDING TO PROCEDURE AND MET ALL REQUIRED SPECIFICATIONS. NO ADDITIONAL REPORTS OF THIS NATURE HAVE BEEN RECEIVED INVOLVING ANY OTHER GRAFTS FROM THE SUBJECT LOT. IT WAS REPORTED THAT THE SURGEON DID NOT SEEM TO THINK THIS INCIDENT WAS DUE TO THE ALLOGRAFT IMPLANT.