MAUDE Adverse Event Report: SYNTHECEL DURA REPR 2.5CMX7.5CM(1"X3")-S; DURA SUBSTITUTE

Model Number	SC.400.019.01S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot: part: sc.400.019.01s, lot: 191216019, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: 05 february 2020, expiration date: 30 september 2022.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on an unknown date, the patient had a retromastoid craniotomy with synthecel implanted for dura repair.Patient had a reaction to the synthecel one (1) month post-op.Patient experienced chemical meningitis.Patient also had stryker direct inject cement used.There is no further information available.This report is for one (1) synthecel dura repr 2.5cmx7.5cm(1"x3")-s.This is report 1 of 1 for (b)(4).

• Brand Name: SYNTHECEL DURA REPR 2.5CMX7.5CM(1"X3")-S
• Common Device Name: DURA SUBSTITUTE
• MDR Report Key: 12745571
• Report Number: 2939274-2021-06462
• Device Sequence Number: 4920332
• Product Code: GXQ
• UDI-Device Identifier: 10887587001364
• UDI-Public: 10887587001364
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K131792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2021

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: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: SC.400.019.01S
• Device Catalogue Number: SC.400.019.01S
• Device Lot Number: 191216019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Weight: 68