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

Model Number	DMS22
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hearing Impairment (1881)
Type of Reportable Event	Serious Injury
Event or Problem Description
Limited information was provided.Clinical data collection site reported duramatrix suturable was used on a patient in q2 2021 for a cranioplasty.The patient experienced hearing loss on the right side.Adherus dural sealant was also utilized during the procedure.No additional event information, patient information, or patient outcome was provided.Complainant confirmed no further information will be provided.
Additional Manufacturer Narrative
Additional quality control testing of samples is pending.
Additional Manufacturer Narrative
Further analysis by quality control and r&d confirmed that no further product testing could be completed that would correlate with the reported issue.All routine testing for the lot in question, which corresponds to the primary inputs for the design of the device at the time of release, produced results that all met acceptance criteria.In cases where additional symptoms are present, testing of the reserve product inventory would be required, however in this reported complaint, no further symptoms were reported.Therefore no further testing could be performed that would directly correlate with the symptom identified in the complaint.

• 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 rd; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 18080112
• Report Number: 2249852-2023-00019
• Device Sequence Number: 6590858
• Product Code: GXQ
• UDI-Device Identifier: 00813954020402
• UDI-Public: (01)00813954020402(17)230331(10)2009241121
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K141608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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: 03/31/2023
• Device Model Number: DMS22
• Device Catalogue Number: DMS22
• Device Lot Number: 2009241121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• 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
• Patient Sex: Unknown