MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX SUTURABLE; COLLAGEN DURA MEMBRANE

Model Number DMS22

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 12/15/2023

Event Type  Injury  

Manufacturer Narrative

Quality control testing of reserve product met acceptance criteria.

Event Description

Customer reported duramatrix suturable was used on a patient during a chiari procedure on (b)(6) 2023.Customer stated adherus was utilized during the original procedure.A post-op csf leak repair was done on (b)(6) 2023.It was noted that the graft had a hole in the middle of it when revision surgery occurred to repair the leak.Patient status and patient information was requested but not provided.

Manufacturer Narrative

Quality control testing of reserve product met acceptance criteria for thermal transition and stuture pull out strength.It is expected the product performed as expected.Further trend analysis by clinical affairs and quality assurance concluded there is no identifiable trend and the rate of complaints does not exceed market standards.

• Brand Name: DURAMATRIX SUTURABLE
• Type of Device: COLLAGEN DURA MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 18628077
• MDR Text Key: 334369853
• Report Number: 2249852-2024-00002
• Device Sequence Number: 1
• Product Code: GXQ
• UDI-Device Identifier: 00813954020402
• UDI-Public: (01)00813954020402(17)241231(10)2206291121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DMS22
• Device Catalogue Number: DMS22
• Device Lot Number: 2206291121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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
• Patient Sex: Female