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

Model Number	C1-4X5
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On september 6th, 2018, acera first received feedback from (b)(6) regarding the product from lot 20147.The feedback described that the product used by dr.(b)(6) from (b)(6) hospital observed a cerebral spinal fluid leak post operation.The patient safety was confirmed.As a result of the received feedback, acera opened a complaint investigation.Acera reviewed the lot record and usage information for lot 20147 products.When products from lot 20147 were exhausted from acera, no other complaints were observed from this lot except for d02-14-c636 from (b)(6).Acera also collected more usage details from the doctor through (b)(6) and discovered that the product was used in an onlay application without tensionless sutures in a cerebellar tumor removal case.The cause of the product was narrowed down to a contra-indicated off-label use in a high-pressure area of the brain.When this event was initially investigated, it was determined to not be reportable because it occurred in (b)(6).But, after future learnings, it was determine that this decision was made in error, and the organization is now reporting this event that occurred in 2018.
Event or Problem Description
During post-op review, it was noticed that the patient had a csf leak.The surgeon decided to operate to address and found that the device (cerafix) may have resorbed too quickly.

• 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: 9696344
• Report Number: 3012429393-2019-00002
• Device Sequence Number: 13873338
• Product Code: GXQ
• UDI-Device Identifier: 00854258006044
• UDI-Public: 854258006044
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K153613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: C1-4X5
• Device Lot Number: 20147
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention