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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX; COLLAGEN DURA SUBSTITUTE MEMBRANE
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COLLAGEN MATRIX, INC. DURAMATRIX; COLLAGEN DURA SUBSTITUTE MEMBRANE Back to Search Results
Model Number CDSM11
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code Adhesion(s) (1695)
Date of Event 02/01/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Actual device was not returned/evaluated due to biohazard contamination (human blood/tissue).Reserve samples from the same lot were tested for suture pull strength and met acceptance criteria.
 
Event or Problem Description
During a posterior lumbar procedure, the surgeon attempted to suture a duramatrix membrane in place.The surgeon was using a prolene suture and even after hydrating the duramatrix the suture tore right through the edges of the membrane.
 
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Brand Name
DURAMATRIX
Common Device Name
COLLAGEN DURA SUBSTITUTE MEMBRANE
Manufacturer (Section D)
COLLAGEN MATRIX, INC.
15 thornton road
oakland NJ 07436
MDR Report Key5456517
Report Number2249852-2016-00004
Device Sequence Number376009
Product Code GXQ
UDI-Device Identifier00813954020181
UDI-Public00813954020181
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K061487
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 02/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Physician
Device Expiration Date01/31/2017
Device Model NumberCDSM11
Device Lot Number1401242022
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/02/2016
Initial Report FDA Received Date02/24/2016
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 Other;
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