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

Model Number	DMS33
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Intracranial Pressure Increased (4586)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported the duramatrix suturable (dms) product was used on a patient in three spearate instances.The product was first implanted in a patient for a spine case on (b)(6) 2023.Adherus was sprayed over the top of the dms.The nature of spine case was requested but not provided.The patient was brought back to surgery on (b)(6) 2023.The surgeon noted the dms was still sutured around the perimeter of the graft, but the middle was "split" open.The surgeon indicated the graft was friable, and attempted to suture the pieces back together.Adherus was sprayed over the graft, surgicel was placed over the top, and more adherus was sprayed over the surgicel.No new dural graft was implanted at this time.The patient was brought back to surgery again on (b)(6) 2023.The nature of the surgery and reason for bringing the patient back was requested not provided.The surgeon explained the dms graft was "friable and fell apart when manipulated with instrumentation." type of instrumentation used was requested but not provided.The dms graft was removed and replaced with another dms.The same item number and same lot number used during the initial surgery on (b)(6) 2023 was used during this surgery on (b)(6) 2023.Adherus was sprayed over the graft.The patient was brought back to surgery for a third time on (b)(6) 2023.The nature of the surgery and reason for bringing the patient back was requested but not provided.The surgeon noted the dms graft was still secured around the perimeter with sutures, but there were two "weep holes" in the graft.Adherus was sprayed over the top of the graft.A duramatrix onlay graft was placed over the top.It was explained the patient was found to have high csf pressure and a shunt was placed.Information and clarification was requested from the customer, including: details surrounding the original spinal procedure and all of the follow-up procedures, the reason for the multiple follow-up procedures, if there were any surgical dealys, clarification on when the high csf pressure occurred and the current patient status.No further information has been provided by the customer.
Additional Manufacturer Narrative
Additional quality control testing of samples is pending.
Additional Manufacturer Narrative
Additional quality control testing of reserve product showed the product met the acceptable criteria for suture pull-out strength testing and thermal transition determination.

• Brand Name: DURAMATRIX SUTURABLE
• Common Device Name: 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: 17907117
• Report Number: 2249852-2023-00017
• Device Sequence Number: 7822903
• Product Code: GXQ
• UDI-Device Identifier: 00813954020419
• UDI-Public: (01)00813954020419(17)250331(10)2209161121
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K141608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/19/2023

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
• Device Expiration Date: 03/31/2025
• Device Model Number: DMS33
• Device Lot Number: 2209161121
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• 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: Other; Required Intervention
• Patient Sex: Unknown