MAUDE Adverse Event Report: ACERA SURGICAL, INC CERAFIX DURA SUBSTITUTE

Model Number	C1-2X2
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the complaint investigation, it was uncovered that the doctor used bioglue during the initial neurosurgery.Cerafix has never been studied in conjunction with bioglue, so, we do not know if there was any interaction between the two products that contributed to the complaint.That said, while cerafix is indicated for neurosurgical use, bioglue is contraindicated for neurosurgical use.Based on its ifu, "bioglue for use in neurosurgery, including use as a dural sealant, is not an approved indication.Fda has not evaluated the safety and effectiveness in support of a neurosurgical indication; however, serious adverse events such as stroke, infection, meningitis, and cerebrospinal fluid leaks have been reported." (b)(4).
Event or Problem Description
Patient returned 2 weeks post-op with a csf leak.

• Brand Name: CERAFIX DURA SUBSTITUTE
• Common Device Name: CERAFIX
• Manufacturer (Section D): ACERA SURGICAL, INC; 7842 hickory flat hwy; ste. b; woodstock, ga
• MDR Report Key: 10479858
• Report Number: 3012429393-2020-00001
• Device Sequence Number: 14054392
• Product Code: GXQ
• UDI-Device Identifier: 00854258006020
• UDI-Public: 854258006020
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K153613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2020

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: 07/31/2020
• Device Model Number: C1-2X2
• Device Lot Number: 26652
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention