INFUSE BONE GRAFT
Received Sep 1, 2017
Report 1030489-2017-01986 · MDR key 6837249
Device
Generic name
Bone Grafting Material, Dental, With Biologic Component
Manufacturer
Medtronic Sofamor Danek Usa, IncModel number
NACatalog number
UNK
Lot number
UNK
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
18 YR
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
IT WAS REPORTED VIA CALL FROM A DOCTOR WHO USED RHBMP-2/ACS IN A DENTAL PROCEDURE. SURGEON USED 2MG KIT OF RHBMP-2/ACS IN COMBINATION WITH ANOTHER ALLOGRAFT DURING THE PROCEDURE. THE SURGEON INDICATED THAT THE PATIENT HAS COME BACK INDICATING THAT THE PROCEDURE DID NOT WORK.