REGENAVATE® FORMABLE DBM RT
Received Jun 26, 2026 · Event occurred Apr 15, 2026
Report 3002719998-2026-00010 · MDR key 25638642
Device
Generic name
Regenavate® Formable Dbm Rt
Manufacturer
Rti Surgical Inc D.b.a. EvergenLot number
101143975
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Failure of Implant
Narrative
Description of Event or Problem
AN INVESTIGATION WAS INITIATED FOLLOWING A COMPLAINT REPORTED TO RTI SURGICAL INC D.B.A. EVERGEN. THE COMPLAINT INDICATED THAT THE CONSISTENCY OF THE REGENAVATE RT MOLDABLE GRAFT MORE PARTICULATE IN NATURE RATHER THAN A COHESIVE PUTTY, WHICH MAKES IT DIFFICULT TO HANDLE IN CERTAIN APPLICATIONS (DENTAL PROCEDURES). WHEN PLACING THE GRAFT MATERIAL INTO A LATERAL INCISION, A PUTTY-LIKE CONSISTENCY IS NEEDED SO THAT IT WILL ADHERE AND REMAIN STABLE WITHIN THE SITE. A PARTICULATE MATERIAL LACKS THAT COHESIVENESS, SO IT TENDS TO FALL AWAY FROM THE DEFECT, MAKING PRECISE PLACEMENT MORE DIFFICULT AND REDUCING PREDICTABILITY IN MAINTAINING THE GRAFT WHERE IT'S NEEDED. THE REPORTER INDICATED THAT SURGICAL / MEDICAL INTERVENTION IS REQUIRED TO PREVENT PERMANENT DAMAGE. ADDITIONAL GRAFT MATERIAL WAS NEEDED. THERE WERE NO SYMPTOMS REPORTED AS A RESULT OF THE EVENT. TWO GRAFTS WERE UTILIZED. THE FIRST REGENAVATE RT MOLDABLE IS BEING SUBMITTED IN MW #3002719998-2026-00009.
Additional Manufacturer Narrative
A FOLLOW UP MDR WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.