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 (b)(6) 2019.An adverse event was reported through a post market survey for copios pericardium membrane for dental applications via qualtrics survey software.The doctor indicated that the membrane failed to integrate due to perimplantitis.Dehiscence, delayed wound healing and revision surgery for failed graft also reported.These events were reported based on his experience using the product over the past 2 years.To date, additional information has not been received.

• Brand Name: COPIOS PERICARDIUM MEMBRANE
• Type of Device: BOVINE PERICARDIUM MEMBRANE
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestrabe; neunkirchen am brand 97077 ; GM 97077
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 9383995
• MDR Text Key: 168447859
• Report Number: 3002924436-2019-00014
• Device Sequence Number: 1
• Product Code: NPL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2019

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
• Device Operator: No Information
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other