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

Lot Number NZS18500120

Device Problem Material Disintegration (1177)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 11/14/2020

Event Type  Injury  

Manufacturer Narrative

The xenograft remains implanted.Therefore, our investigation is based on a comprehensive review of production records and evaluation of patient medical information provided.Once the results of the investigation are available, a follow up report will be submitted.

Event Description

Rti surgical, inc (rti) received an adverse event complaint from our distributor intregra life sciences on 10/27/2020.The reported complaint indicated that a (b)(6)-y.O.Male patient underwent surgery with implantation of a duraflex graft on (b)(6) 2020.The patient developed a csk leak post-operatively.Additional information was received indicating that on 11/14/2020, the patient underwent surgical intervention to correct the csf leak.During surgery it was noted that the duraflex graft had a hole in the middle.The edges of the graft had sealed properly.

Manufacturer Narrative

A comprehensive re-review of the manufacturing records was conducted.There were no departures that would negatively impact the implants manufactured from lot nzs18500120.Bovine pericardium implants undergo a validated sterilization method: tutoplast® which includes terminal sterilization by gamma irradiation after packaging.Manufacturing records indicated that serial id (b)(6) met all specification requirements at the time of release.To date, rti/tmi has manufactured and distributed a total of 3 implants from the lot without related complaints.Integra duraflex suturable dural grafts are a natural, resorbable collagenous device.The absorption and tissue regeneration processes begin one to two days after implantation and may last for weeks on months.The most common causes for failure of the regeneration process are associated with the medical history of the patient (i.E.Diabetes, allergic reaction) and level of compliance with post-operative instructions.Additional information is needed to better understand and possibly explain the complications reported, including whether the patient has an allergy to bovine collagen and/or bovine material, patient's medical history and compliance with post-operative care.Given the facts that: (1) rti records re-review results indicated that bovine pericardium implants manufactured from lot nzs18500120 met all specification requirements and release criteria at the time of distribution; (2) bovine pericardium implants from the complaint lot were processed utilizing a validated sterilization method, tutoplast® which includes terminal sterilization by gamma irradiation after packaging; and (3) additional patient medical information was not provided, the surgical outcome of the recipient is more likely associated with one or more extrinsic factors, rather than an intrinsic property of the bovine pericardium implant.

• Brand Name: DURAFLEX DURAL GRAFT
• Type of Device: BOVINE PERICARDIUM DURAL SUSBSTITUTE GRAFT
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestr 6; neunkirchen am brand 91077 ; GM 91077
• MDR Report Key: 10907235
• MDR Text Key: 218664492
• Report Number: 3002719998-2020-00015
• 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
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: NZS18500120
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR