MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S; SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Vision (2139); Embolism/Embolus (4438)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient undergoing surgery for a herniated disc in the cervical spine.Peroperative bleeding treated with surgiflo.Postoperatively affected cognition is why the patient is sent as a possible stroke case.Investigation shows small emboli in the cerebellum.Suspicion of surgiflo in arteria vertebralis.No damage to arteria vertibralis has been confirmed on ct angio.During the operation, it was ensured that the bleeding was venous.More detailed description of patient/user sequence: effects on syncortex, partial blindness.
Event or Problem Description
Patient undergoing surgery for a herniated disc in the cervical spine.Peroperative bleeding treated with surgiflo.Postoperatively affected cognition is why the patient is sent as a possible stroke case.Investigation shows small emboli in the cerebellum.Suspicion of surgiflo in arteria vertebralis.No damage to arteria vertibralis has been confirmed on ct angio.During the operation, it was ensured that the bleeding was venous.More detailed description of patient/user sequence: effects on syncortex, partial blindness.

• Common Device Name: SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• MDR Report Key: 19041209
• Report Number: 3008478369-2024-00016
• Device Sequence Number: 12903041
• Product Code: LMF
• UDI-Device Identifier: 25712123000285
• UDI-Public: 25712123000285
• Combination Product (Y/N): Y
• PMA/510(K) Number: P990004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/05/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown