PLEXUR P
Received Jun 23, 2008
Report 2246640-2008-00003 · MDR key 1064475
Device
Generic name
Resorbable Bone Void Filler
Manufacturer
Osteotech, Inc.Model number
GRANULES, 20CCCatalog number
6000-020
Lot number
OTSCT5100170
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNK
- Unspecified Infection
Narrative
Description of Event or Problem
PATIENT HAD DEVICE IMPLANTED IN 2005. SALES AGENCY PERSONNEL REPORTED IN 2008, THAT PATIENT HAD DEVELOPED A POST-OPERATIVE INFECTION. SURGEON CLAIMS IT WAS DUE TO DEVICE. NO FURTHER INFORMATION AS TO PATIENT CONDITION, IDENTIFY OF ORGANISM, TREATMENT AND PROGNOSIS WERE PROVIDED. FOLLOW-UP CALLS TO SALES AGENT AND HOSPITAL PERSONNEL DID NOT PROVIDE ADDITIONAL INFORMATION AS OF 6/20/08.
Additional Manufacturer Narrative
SEVERAL ATTEMPTS AT OBTAINING SPECIFIC INFORMATION FROM THE SALES AGENT AND HOSPITAL PERSONNEL HAVE NOT BEEN SUCCESSFUL TO DATE. AS NO PRODUCT WAS AVAILABLE TO EVALUATE, ALL LOT PROCESSING RECORDS WERE REVIEWED FOR COMPLIANCE TO PROCEDURE. STERILITY, ENVIRONMENTAL, CLEANING, FACILITY, EQUIPMENT AND PERSONNEL RECORDS WERE REVIEWED AND FOUND TO COMPLY. NO ORGANISMS WERE IDENTIFIED THROUGHOUT THE PROCESS. THE PRODUCT IS TERMINALLY STERILIZED AFTER PACKAGING; STERILIZATION PARAMETERS COMPLIED.