MEMBRAGEL

MDR report key: 2406187 · Received January 6, 2012

Report

Report Number: 1222315-2012-00002
Event Type: Injury
Date Received: January 6, 2012
Date of Event: September 21, 2011
Report Date: January 6, 2012
Manufacturer: INSTITUT STRAUMANN AG
Product Code: NPK
PMA / PMN Number: K101956
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 1

THE BATCH RECORD REVIEW HAS BEEN CARRIED OUT AND CONFIRMS THAT THE PRODUCT WAS WITHIN SPECIFICATION.

Description of Event or Problem · 1

BONE AUGMENTATION WITHOUT IMPLANTATION PROCEDURE CARRIED OUT ON (B)(6) 2011: SURGERY REGIO 21 WITH BONECERAMIC AND MEMBRAGEL. BONE DEFECT LARGE, ALSO WITH SIDE DEFECTS SO IMPLANT CAN NOT BE PLACED. PERFORATION APPLIED / ALVEOLE FILLED WITH A LITTLE OVERFILL / MEMBRAGEL PLACED CLEANLY / BONE WAS DRY DURING PLACEMENT / PERIO-CUT TO 23 / AREA WITH OVERRUN STRESS-FREE. (B)(6) 2011 SOME PAIN AND SWELLING / WOUND HEALING GOOD / PT DID NOT SMOKE, ONLY SMOKING HASH. (B)(6) 2011 NO PAIN / PT DID NOT SMOKE, ONLY SMOKING HASH / NO SWELLING / NO DEHISCENCE. (B)(6) 2011 UNDER PRESSURE A LOT OF PUS. (B)(6) 2011 STILL UNDER PRESSURE A LOT OF PUS MIXED WITH GRANULATE / REMOVAL OF CONSTRUCTION IS PLANNED. (B)(6) 2011 REMOVAL OF BONE AUGMENTATION / RECOMMENDATION: ADHESIVE BRIDGE. (B)(6) 2011 PT HAD STRONG PAIN. (B)(6) 2011 WOUND HEALING WELL / REMOVAL OF SUTURE. (B)(6) 2011 EVERYTHING IS GOOD / UNDER PRESSURE LESS PUS OUT OF ALVEOLE / RINSING WITH NACL-SOLUTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MEMBRAGEL	PROD CODE NPK - BARRIER MEMBRANE	NPK	INSTITUT STRAUMANN AG		Z5927

Patients

Seq	Age	Sex	Outcome	Treatment
1	18 YR		Required Intervention	EXPIRE DATE 06/30/2015, PROD CODE LYC - SYNTHETIC\| BONE CERAMIC: CATALOG # 070.203, LOT Y8039,\| BONE GRAFTING MATERIAL