MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DURA SUBSTITUTE DUREPAIR 2X2 IN

Model Number	62100
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Other
Event or Problem Description
Durepair dura regeneration matrix - all lot numbers - urgent medical device recall.

• Brand Name: DURA SUBSTITUTE DUREPAIR 2X2 IN
• Common Device Name: DURA SUBSTITUTE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 17192266
• Report Number: MW5118728
• Device Sequence Number: 12183402
• Product Code: GXQ
• UDI-Device Identifier: 00643169063853
• UDI-Public: 00643169063853
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2023

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?: No
• Device Model Number: 62100
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown