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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX SUTURABLE; COLLAGEN DURA MEMBRANE
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COLLAGEN MATRIX, INC. DURAMATRIX SUTURABLE; COLLAGEN DURA MEMBRANE Back to Search Results
Model Number DMS45
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code Cerebrospinal Fluid Leakage (1772)
Date of Event 06/26/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a patient required initial revision surgery due to a breakdown of the graft and csf leak.Further clarification reported that sutures were used to repair the leakage.The patient then required a second revision surgery after a hole and csf leak were noticed.The graft was removed and replaced with auto graft from the patient's leg.The patient was reported to be healing well.
 
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Brand Name
DURAMATRIX SUTURABLE
Common Device Name
COLLAGEN DURA MEMBRANE
Manufacturer (Section D)
COLLAGEN MATRIX, INC.
15 thornton road
oakland NJ 07436
MDR Report Key10535448
Report Number2249852-2020-00009
Device Sequence Number14055898
Product Code GXQ
UDI-Device Identifier00813954020426
UDI-Public00813954020426
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K141608
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/15/2020
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 No Information
Device Expiration Date12/31/2021
Device Model NumberDMS45
Device Lot Number1906181121
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/18/2020
Initial Report FDA Received Date09/15/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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