MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH COPIOS PERICARDIUM MEMBRANE; BOVINE PERICARDIUM MEMBRANE

Lot Number NOT PROVIDED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Unique identifiers were not provided in order to conduct a comprehensive records re-review.If additional information is provided, a follow-up report will be submitted.

Event Description

Rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly owned subsidiary of rti, received a complaint on 10/29/19.The information documented on the post market survey for copios pericardium membranes (cpms) for dental applications performed within the past two years indicated that 50 dental procedures were performed and some of the patients had experienced <1% of dehiscence failed tissue augmentation and bone loss.For resorption/liquidation, 1 5% of the patients experienced this complication.To date, no additional information has been provided.

Event Description

A doctor with 10 years of experience in using copios pericardium membrane for dental applications has performed approximately 10 cases with the xenograft per year.The copios pericardium membrane was used with allografts.The ease of manipulation and product aesthetics met the doctor's expectations.Several attempts to obtain patient and product information were made without success.

Manufacturer Narrative

Since there is neither patient individual data nor product specific data available, the reported adverse events cannot be assessed on an individual basis.No causality assessment could be performed on an individual basis.

• Brand Name: COPIOS PERICARDIUM MEMBRANE
• Type of Device: BOVINE PERICARDIUM MEMBRANE
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestrasse 6; neunkirchen am brand 91077 ; GM 91077
• MDR Report Key: 9350310
• MDR Text Key: 167324581
• Report Number: 3002924436-2019-00009
• Device Sequence Number: 1
• Product Code: NPL
• Combination Product (y/n): N
• PMA/PMN Number: K142070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other