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

Model Number CDSM33

Device Problems Device remains implanted (1526); Repair (1529)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2014

Event Type  malfunction  

Event Description

While the surgeon was attempting to close the dura using duramatrix after addressing a chiari malformation, the graft tore.

• Brand Name: DURAMATRIX
• Type of Device: COLLAGEN DURA SUBSTITUTE MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton rd; oakland, NJ 07436 ; 2014051477
• MDR Report Key: 4080190
• MDR Text Key: 4746419
• Report Number: 2249852-2014-00005
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040888
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: CDSM33
• Device Lot Number: 1306283022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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 Age: 12 YR