MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH TUTOPATCH® DURAL SUBSTITUTE; DURAL GRAFT SUBSTITUTE

Lot Number NOT PROVIDED

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

Patient Problems Fistula (1862); Unspecified Infection (1930); Meningitis (2389)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly subsidiary of rti, received a complaint on (b)(6) 2020.An adverse event was reported through a post market survey for tutopatch® for dura substitution application via qualtrics survey software.The doctor indicated that in his 8 years of experience using the product, < 1% of this patients/cases have experienced infection, brain abscess, csf fistulas, meningitis and pseudomeningocele.Additional information has been requested.To date, no additional information has been received.

• Brand Name: TUTOPATCH® DURAL SUBSTITUTE
• Type of Device: DURAL GRAFT SUBSTITUTE
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestrabe 6; neunkirchen am brand 97077 ; GM 97077
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, fl ; 4188888436
• MDR Report Key: 9788686
• MDR Text Key: 188687158
• Report Number: 3002924436-2020-00010
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K132850
• 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: 03/04/2020

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: Health Professional
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 03/04/2020
• 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