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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH COPIOS PERICARDIUM MEMBRANE; BOVINE PERICARDIUM MEMBRANE, PRODUCT CODE: NPL
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TUTOGEN MEDICAL GMBH COPIOS PERICARDIUM MEMBRANE; BOVINE PERICARDIUM MEMBRANE, PRODUCT CODE: NPL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Failure of Implant (1924)
Event Date 10/29/2019
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
An adverse event was reported through a post market survey for copios pericardium membrane for dental applications via (b)(4) software.The doctor indicated that 5-10% of the patients/cases have experienced dehiscence, failed tissue augmentation/bone loss, resorption/liquidation and revision surgery for failed graft.
 
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Brand Name
COPIOS PERICARDIUM MEMBRANE
Type of Device
BOVINE PERICARDIUM MEMBRANE, PRODUCT CODE: NPL
Manufacturer (Section D)
TUTOGEN MEDICAL GMBH
industriestrasse 6
Manufacturer Contact
charity emmons
11621 reserach circle
alachua, FL 32615
3864188888
MDR Report Key9383778
MDR Text Key184884323
Report Number3002924436-2019-00013
Device Sequence Number1
Product Code NPL
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K142070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/29/2019
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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