InjuryLEM
LYOPHILIZED DURA MATER
Received Aug 22, 1996 · Event occurred Feb 8, 1996
Report MW4001714 · MDR key 51519
Device
Generic name
Lyophilized Dura Mater
Manufacturer
Transplantation Research FoundationModel number
TISSUE CATEGORY CODE TRF-010Catalog number
*
Lot number
D-8284-95
Product problems
- Microbial Contamination of Device
Patient
69 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
PT UNDERWENT SURGERY ON 2/8/96 WHICH INCLUDED THE USE OF FREEZE DRIED DURA MATER BONE GRAFT. PRIOR TO IMPLANTATION, THE SURGEON OBTAINED A SAMPLE OF THE DURA MATER AS SOON AS IT WAS TAKEN FROM THE CONTAINER. THIS WAS DONE USING STERILE TECHNIQUE. THE SAMPLE WAS SENT TO THE LAB FOR C/S AND ANEROBIC CULTURES. ON 2/12/96, THE SURGEON WAS NOTIFIED THAT THE MICROBIOLOGICAL REPORT FROM THE SPECIMEN WAS POSITIVE FOR "RARE STAPHYLOCOCCUS SPECIES (COAGULASE NEGATIVE), BETA LACTAMASE".