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

Lot Number NZ18450064

Device Problem Degraded (1153)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Manufacturer Narrative

The xenograft was not available to return for inspection as it remains implanted.Therefore, a comprehensive re-review of manufacturing records, quality control/assurance reviews and release, and complaint database for related complaints associated with the lot was conducted.There were no departures noted during records re-review that would negatively affect the manufacturing of xenografts from lot nz18450064.All bovine pericardium implants undergo a validated sterilization method (tutoplast® which includes terminal sterilization by gamma irradiation after packaging).Manufacturing records indicate that all xenografts implants manufactured from this lot met all specifications and release criteria prior to distribution.To date, rti has manufactured and distributed a total of 11 xenograft implants, without related complaints for the lot.Additional information is needed to better understand and possibly explain the complications reported, including information regarding the preparation of the xenograft prior to implantation, suture procedure and suture material utilized, whether the graft was fixed under tension, and whether the patient has an allergy to bovine collagen and/or bovine material.

Event Description

Rti surgical, inc (rti) received an adverse event complaint from (b)(4) on 08/11/2020 the reported complaint indicated that the graft dissolved post transplantation.Additional information has been requested from (b)(4) (distributor) and the facility.To date, no additional information has been received.

• Brand Name: DURAFLEX DURAL GRAFT
• Type of Device: BOVINE PERICARDIUM DURAL SUBSTITUTE GRAFT
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestr 6; neunkirchen am brand, 91077 ; GM 91077
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 10515585
• MDR Text Key: 206508024
• Report Number: 3002719998-2020-00008
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: NZ18450064
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2020
• 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