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

Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Pain (1994); Stenosis (2263)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post-op of an anterior corpectomy procedure the during an mri it showed the surgiflow (corrected to surgiflo¿) was "creeping around" causing stenosis.Patient was brought back to or to scrape out the surgiflow (corrected to surgiflo¿).Patient is now doing fine.The surgeon removed the surgiflo during the 2nd procedure.
Event or Problem Description
It was reported that post-op of an anterior corpectomy procedure the during an mri it showed the surgiflow (corrected to surgiflo¿) was "creeping around" causing stenosis.Patient was brought back to or to scrape out the surgiflow (corrected to surgiflo¿).Patient is now doing fine.The surgeon removed the surgiflo during the 2nd procedure.Follow-up information: surgiflo was used to control bleeding in an anterior corpectomy.Surgiflo was used for adjunctive hemostasis.It is unknown whether excess surgiflo was removed.

• Common Device Name: SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• Manufacturer Contact: sydmarken 5; soeborg, 2860
• MDR Report Key: 18118002
• Report Number: 3008478369-2023-00014
• Device Sequence Number: 15329121
• Product Code: LMF
• UDI-Device Identifier: 15712123000288
• UDI-Public: 15712123000288
• 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: 11/13/2023
• Supplement Report FDA Received Date: 12/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown