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

Model Number	CDSM33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Quality control testing on reserve samples confirmed that the prouct met acceptance criteria for visual inspection, thermal transition temperature and suture pull out strength testing.
Event or Problem Description
The clinician performed a posterior fossa decompression for chiari malformation and holocord syrinx utilizing duraplasty technique.Initial surgery was performed on (b)(6) 2024.After performing the decompression, the clinician was sewing in the duramatrix graft.Clinician reported that two sides of the graft "sutured fine." the top line, unfortunately, shredded and tore with any touch, whether then clinician was trying to put a stick in it or just grab it and hold it with a pick-up (toothed or not).The clinician attempted to suture to the middle of the graft with the same poor results.The clinician also tried to place a patch graft and had the same problem of tearing with minimal manipulation.The clinician tried to reinforce with tisseal, dural onlay (duragen), and adherus; these products are not manufactured by collagen matrix, inc.Due to the "poor results" from the duramatrix, the initial surgery was delayed by 1.5 hours.A external ventricular drainage (evd) was placed on (b)(6) 2024.Revision surgery was performed on (b)(6) 2024 for worsening pseudomeningocele despite aggressive csf drainage.No further information provided on patient status or patient outcome.Information surrounding adverse event date was requested but not clarified.
Event or Problem Description
The clinician performed a posterior fossa decompression for chiari malformation and holocord syrinx utilizing duraplasty technique.Initial surgery was performed on (b)(6) 2024.After performing the decompression, the clinician was sewing in the duramatrix graft.Clinician reported that two sides of the graft "sutured fine." the top line, unfortunately, shredded and tore with any touch, whether then clinician was trying to put a stick in it or just grab it and hold it with a pick-up (toothed or not).The clinician attempted to suture to the middle of the graft with the same poor results.The clinician also tried to place a patch graft and had the same problem of tearing with minimal manipulation.The clinician tried to reinforce with tisseal, dural onlay (duragen), and adherus; these products are not manufactured by collagen matrix, inc.Due to the "poor results" from the duramatrix, the initial surgery was delayed by 1.5 hours.On (b)(6) 2024 the patient went to the er and had a csf leak.The patient was admitted to the icu.The clinician noted "the patient has had numerous labs and ivs and will require antibiotics and diamox and surgery tonight and likely tomorrow morning to try and stop the leaking and will likely require additional surgeries over the next week to month." a external ventricular drainage (evd) was placed on (b)(6) 2024.Revision surgery was performed on (b)(6) 2024 for worsening pseudomeningocele despite aggressive csf drainage (csf leak repair with alloderm).Additional clinic follow-up visits scheduled on (b)(6) 2024, no additional surgeries scheduled.Nature surrounding clinic follow-up visits have not been specified.No further information provided on patient status or patient outcome.

• Brand Name: DURAMATRIX
• Common Device Name: DURAMATRIX COLLAGEN DURA SUBSTITUTE 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: 19615904
• Report Number: 2249852-2024-00010
• Device Sequence Number: 15029005
• Product Code: GXQ
• UDI-Device Identifier: 00813954020211
• UDI-Public: (01)00813954020211(17)261031(10)2310131022
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K040888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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
• Operator of Device: Health Professional
• Device Model Number: CDSM33
• Device Catalogue Number: CDSM33
• Device Lot Number: 2310131022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown