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

Device Problem Insufficient Information (3190)

Patient Problems Cerebrospinal Fluid Leakage (1772); Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

As no unique lot or serial numbers were provided, a comprehensive re-review of the lot, manufacturing, and/or internal records could not be conducted.If additional information becomes available, a follow-up report will be submitted.

Event Description

On (b)(6) 2022, rti surgical, inc.And tutogen medical gmbh (tmi), a wholly subsidiary of rti surgical, received a complaint through conducting a literature search.The article was in reference to melanotic neuroectoduermal tumor of infancy to the skull: case-based review.The grafts discussed in the article were tutobone® (not distributed in the us) and tutopatch®.Melanotic neuroectodermal tumor of infancy (mnti) is a rare tumor which usually occurs in infants under the age of one.The standard management of mnti is surgical resection.Tutopatch® was utilized for a duraplasty.Tutobone® and absorbable plates were utilized for the frontotemporal bone reconstruction in the case for a 4-month-old male child who presented with a progressive right-sided swelling at his hairline.The post-operative course was uneventful and the patient was discharged on the 6th post-operative day without neurological sequelae.The patient returned for a three month mri follow-up.Results showed local recurrence of the tumor at the sphenoid bone and lateral orbit on the right side.Due to the young age of the patient and the short period to recurrence, the initiation of chemotherapy was recommended.Three weeks later and prior to starting the chemotherapy, it was discovered that the patient had developed a large pseudomeningocele, which recurred despite local punctures.This led to the patient having to undergo multiple local duraplasty revision procedures and csf diversion procedures were undertaken in an effort to control his pseudomeningocele issues.The patient returned two months later and underwent another mri.The results showed no evidence of tumor recurrence.It was advised to have the patient hold off on starting the chemotherapy and to return for a mri every three months until the patient is two years old.To date, no additional information has been provided.

• Brand Name: TUTOPATCH® DURAL SUBSTITUTE
• Type of Device: DURAL GRAFT 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 ; 3864188888
• MDR Report Key: 15245514
• MDR Text Key: 298114223
• Report Number: 3002924436-2022-00011
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K132850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/17/2022
• 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
• Patient Age: 4 MO
• Patient Sex: Male