GRAFTON DBM
Received Feb 4, 2011 · Event occurred Aug 1, 2009
Report 2246640-2011-00001 · MDR key 1983910
Device
Generic name
Resorbable Bone Void Filler
Manufacturer
Osteotech, Inc.Model number
NACatalog number
UNK
Lot number
UNK
Product problems
- Insufficient Device Problem Information
Patient
8 YR
- No Information
Narrative
Additional Manufacturer Narrative
INFO IN THIS MEDWATCH FORM 3500A WAS COMPLETED BY OSTEOTECH, INC. USING INFO PROVIDED IN THE FOLLOWING LITERATURE CITATION. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT BEING PROVIDED IN THE JOURNAL ARTICLE. LITERATURE ARTICLE CITATION: THAWRANI D, ET. AL. SUCCESSFUL TREATMENT OF UNICAMERAL BONE CYST BY SINGLE PERCUTANEOUS INJECTION OF ALPHA-BSM. J PEDIATR ORTHOP. JUL-AUG 2009; 29(5): 511-7. A REVIEW OF THE MANUFACTURING RECORDS FOR THE GRAFTON DBM PRODUCT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. NEITHER THE DEVICE NOR X-RAYS OF THE APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem
AS REPORTED IN THE LITERATURE, THE PT WAS A SUBJECT IN A STUDY TO EVALUATE CLINICAL AND RADIOGRAPHIC OUTCOMES OF UNICAMERAL BONE CYST TREATMENT USING A SINGLE INJECTION OF APATITIC CALCIUM PHOSPHATE (ALPHA-BSM). IT WAS REPORTED IN THE ARTICLE THAT THE PT HAS HAD "PAST UNSUCCESSFUL TREATMENT" OF A UNICAMERAL BONE CYST USING" DEMINERALIZED BONE MATRIX (GRAFTON) INJECTION."