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

Catalog Number BP10405

Device Problems Material Disintegration (1177); Material Puncture/Hole (1504); Material Rupture (1546)

Patient Problems Cerebrospinal Fluid Leakage (1772); Failure of Implant (1924)

Event Date 09/16/2023

Event Type  Injury  

Manufacturer Narrative

A comprehensive records re-review will be conducted.Once the results are available, a follow-up report will be submitted.

Event Description

Rti surgical inc.(rti) received a complaint on 09/25/2023.The reported complaint indicated that the patient had a chiari malformation and underwent a surgical procedure with implantation of an integra duraflex suturable graft (lot # is unknown) on (b)(6) 2023.On (b)(6) 2023, the patient underwent emergency surgery for incision and drainage procedure in the posterior neck due to a cerebrospinal fluid leak.During the procedure, visual examination of the graft showed the graft had thinned out and leakage was present in the middle or the interior portion of the graft; the graft had dissolved in the middle.(voluntary report mw5146289).A second integra duraflex suturable graft was then implanted (lot # nza19460204; manufacturer report 3002719998-2023-00019; voluntary mw5146291).The graft weakened in the middle during implantation and was removed.A third integra duraflex suturable graft was then implanted (lot # nza22040112; manufacturer report 3002719998-2023-00020; voluntary report mw5146291) which also dissolved in the middle and was explanted.Lastly, a duragen® suturable graft (not manufactured by rti) was implanted.On (b)(6) 2023, the patient underwent additional intervention due to the deterioration of the duragen® implant near the suture line.The holes around the suture line had enlarged resulting in the graft being explanted and replaced with a new product (brand and manufacturer are unknown).To date, no additional information has been provided to rti for review.

Manufacturer Narrative

The graft was discarded at the facility and not available for evaluation at rti.No unique serial id or lot number was provided; therefore, a comprehensive re-review of the batch record could not be performed.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, infection, poor glycemic control, medications (e.G.Steroids), physical location of the surgical site, allergic reactions to bovine material, bacterial or viral infection, inflammation, or non-adherence to implant package insert instructions.Cumulative risk factors increase the likelihood of complications.Additional information is needed to better understand and possibly explain the reported complications.Information regarding membrane rehydration process prior to use, suture procedure and suture material utilized, whether the membranes were fixated under tension, other products used in the case (sealants), and if the patient had an allergy to bovine collagen and/or bovine material.It is more plausible that the patient's adverse event is associated with a source or event extrinsic to the duraflex graft.

• Brand Name: DURAFLEX DURAL GRAFT
• Type of Device: BOVINE PERICARDIUM DURAL SUBSTITUTE
• 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 ; 3865186607
• MDR Report Key: 18015702
• MDR Text Key: 326649689
• Report Number: 3002719998-2023-00018
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BP10405
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention