MAUDE Adverse Event Report: BIOM'UP SA RENOVIX GUIDED HEALING COLLAGEN MEMBRANE; DENTAL MEMBRANE

Model Number	RENOVIX-15X25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device - a resorbable collagen dental membrane - was one of three devices used in the procedure.The doctor removed the membrane and implant and cleaned the tissues at the site of the infection.The membrane is the subject of a class ii medical device recall (z-1110-2017) which was initiated approximately one month after the subject procedure.The reason for initiating the recall was due to a sterilization dose audit failure in which subsequent investigation identified a single bacteria type remaining present after the low audit dose exposure - below the actual sterilization dose used in normal production.The bacteria is susceptible to the full irradiation dose used in normal production.Retained samples from the same lot were tested and determined to be sterile.A culture of the infection site was not performed therefore a definitive conclusion as to whether the bacteria that caused the infection was the bacteria identified in the recall cannot be reached.Moreover, it cannot be determined whether the infection was solely the result of the surgical procedure.Thus, because it cannot be determined whether or not the device contributed to the infection, out of an abundance of caution, the company is reporting this event.Device not returned to manufacturer.
Event or Problem Description
Doctor reported infection at tooth site 10 where membrane, bone graft, and dental implant were used.

• Brand Name: RENOVIX GUIDED HEALING COLLAGEN MEMBRANE
• Common Device Name: DENTAL MEMBRANE
• Manufacturer (Section D): BIOM'UP SA; 8 allee irene joliot-curie; saint priest, rhone 69800 ; FR 69800
• MDR Report Key: 6521173
• Report Number: 3007702492-2017-00002
• Device Sequence Number: 781526
• Product Code: NPL
• UDI-Device Identifier: 03760193181975
• UDI-Public: (01)03760193181975
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K103087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Dentist
• Device Expiration Date: 03/31/2019
• Device Model Number: RENOVIX-15X25
• Device Catalogue Number: RENOVIX-15X25
• Device Lot Number: MCG16003.133037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2017
• Initial Report FDA Received Date: 04/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention