MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN DURAPLASTY GRAFT; DURALPLASTY GRAFT

Model Number	G34979
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930)
Date of Event	09/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device lot history record indicated the device was manufactured to specifications.A total of 10 devices was produced from the lot.A review of the cbi complaint database did not reveal any additional complaints involving the reported lot number.Per the ifu, the device is supplied sterile to the end user.The device should be used "with caution in infection regions." infection is noted amongst the list of potential complications.The root cause, of the abscess and infection, is not likely device related.Such an occurrence could be procedure related and/or acquired post operatively.Cook biotech incorporated has a validated sterilization cycle with a sterility assurance level of (sal) 10^-6.The validated sterility cycle and all parameters of all devices are verified prior to release for distribution.
Event or Problem Description
Professor (b)(6) performed an endoscopic transnasal repair of a skull base fracture in the anterior ethmoid roof.The (b)(6) 2018 procedure included implanting a biodesign duraplasty graft in the (b)(6) female patient.Prior to surgery the patient presented with a spontaneous csf leak and had a known history of generalized seizures.The patient had an uneventful recovery and was seen post repair regularly.On (b)(6) 2018, the patient presented with a generalized grand-mal seizure.An urgent brain ct showed a possible small intracranial abscess at the graft site.The patient was admitted to the icu and underwent emergency surgery to explant the graft.The patient was in the hospital for 7 days on antibiotics.The patient recovered and was discharged.

• Brand Name: BIODESIGN DURAPLASTY GRAFT
• Common Device Name: DURALPLASTY GRAFT
• Manufacturer (Section D): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• MDR Report Key: 7978687
• Report Number: 1835959-2018-00012
• Device Sequence Number: 1382144
• Product Code: GXQ
• UDI-Device Identifier: 10827002349794
• UDI-Public: (01)10827002349794(17)190419(10)LB1033082
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K131015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2018

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: 04/19/2019
• Device Model Number: G34979
• Device Catalogue Number: ENT-CBD-5X5
• Device Lot Number: LB1033082
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE WERE REPORTED BY THE COMPLAINANT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Weight: 65