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); Unspecified Infection (1930)

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) 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 in the past 2 years, 1 - 5% of his patients/cases have experienced dehiscence and failed tissue augmentation/bone loss, 1 - 5% have experienced suppuration and less than 1% have experienced infection, lost tooth implant and revision surgery for failed graft.To date, no additional information has been received.

• Brand Name: COPIOS PERICARDIUM MEMBRANE
• Type of Device: BOVINE PERICARDIUM MEMBRANE
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestrabe 6; neunkirchen am brand 97077 ; GM 97077
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 9401310
• MDR Text Key: 168864478
• Report Number: 3002924436-2019-00018
• Device Sequence Number: 1
• Product Code: NPL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K142070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2019
• 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