MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH INTEGRA BOVINE PERICARDIUM DURAL GRAFT; DURAL GRAFT SUBSTITUTE

Lot Number NOT PROVIDED

Device Problem Degraded (1153)

Patient Problem No Information (3190)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Unique product identifiers were requested.Per the distributor, the physician would not release any additional information regarding this event.Therefore, rti was unable to conduct an investigation.If additional information is provided, a follow up report will be submitted.

Event Description

Rti surgical, inc (rti) received a complaint indicating that a patient was implanted with an integra bovine pericardium dural substitute graft and within 5 weeks it was disintegrating.Additional information was requested, including full name of the physician and contact information.At this time, (b)(4) (the distributor) has not provided physician information.Per the distributor, the physician will not release any additional information.

• Brand Name: INTEGRA BOVINE PERICARDIUM DURAL GRAFT
• Type of Device: DURAL GRAFT SUBSTITUTE
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestr 6; neunkirchen am brand, germany 91077 ; GM 91077
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 7583181
• MDR Text Key: 110510656
• Report Number: 3002719998-2018-00008
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• PMA/PMN Number: K132850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Lot Number: NOT PROVIDED
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other