MAUDE Adverse Event Report: TUTOGEN MEDICAL, GMBH TUTOPATCH

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

To date, no unique identifiers have been 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.And tutogen medical gmbh (tmi) , a wholly subsidiary of rti surgical, received a complaint that indicated: on an unknown date, the facility asked the surgeon about the remodeling process of the tutopatch graft after implantation.The facility asked specifically about the perfusion of the dural replacement? the facility also wanted to know if it was conceivable that tutopatch could be a source of a low grade infection after the conversion process? to date, no additional information has been provided for review.

Manufacturer Narrative

Frequency for csf leaks or pseudomeningocele in conjunction with the tutopatch xenograft is very low with a 0.014% and 0.003% respectively.Furthermore, a survey was submitted to the physicians who use tutopatch grafts.The users who responded, confirmed that the product fulfilled their expectations with regards to a tight closure.Only 12.5% of those who responded reported a rate of 1-5% for csf leaks and <1% for pseudomeningocele.The surgeon asked what was the possibility that a tutopatch graft could be the source of a low grade infection in a patient after conversion? the answer to this question first addressed the sterilization process tutopatch grafts undergo.The process; tutoplast® includes gamma irradiation at a validated dose to achieve a sterility assurance level (sal) of 10-6 prior to release.The microbial challenge used to validate an irradiation dose anticipates potential for aerobic and anaerobic contamination commonly found on donated tissue.The irradiation dose is based on an overkill principle to achieve the desired sal.Iso/aami standard 11137 is the fda recognized standard used to establish this level of confidence.Two clinical trials in which tutopatch grafts have been used as dura substitute showed either no infections or a probability occurance rate of 1.1%.None of the reported cases were directly associated with the tutopatch graft being the source of the infection.To date, additional information has not been provided.A general question was asked by the surgeon if the tutopatch graft could be considered a source for the patient's low grade infection after conversion.The physician stated that the tutopatch graft could almost but not completely be excluded from the possibility that it was contaminated prior to implantation and therefore the source of the infection.The patient had several medical interventions and revisions of the initial craniotomy and peek implant placements.There are several confounders that may have also caused the reported infection.Cutibacterium acnes (formerly propionibacterium acnes) is commonly found on human skin.It was also reported that due to the non-removal of the tutopatch graft, a biofilm developed on the graft over the years that now prevents response to treatment.Rti germany was not able to perform a re-review of the batch documentation associated with the tutopatch complaint graft no unique product identifiers were provided.Although implant therapy is highly successful and predictable, it is not without possible early and/or late complications.Examples include decreased blood supply at the surgical site, poor soft tissue coverage, weight, compliance with therapy, infection, poor glycemic control, medications (e.G.Steroids), physical location of the surgical site, bacterial or viral infection, inflammation, or non-adherence to graft package insert instructions.Infections after surgical procedures are a well-known phenomenon and may be caused by an unsterile handling.Those infections may trigger inflammation, wound dehiscence as well as implant and transplant failure.It is more plausible that the patient's surgical outcome was associated with a source or event extrinsic to the tutopatch graft.

• Brand Name: TUTOPATCH
• Type of Device: TUTOPATCH
• Manufacturer (Section D): TUTOGEN MEDICAL, GMBH; industriestrasse 6; neunkirchen am brand, deu 91077 ; GM 91077
• Manufacturer Contact: karen britt ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 14774950
• MDR Text Key: 294508158
• Report Number: 3002924436-2022-00006
• 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: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other