MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION DURAGEN-UNKNOWN PRODUCT ID; PLAINSBORO

Catalog Number	XXXDUR
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
During a poster presentation at the (b)(6) neurosurgical society event held on (b)(6) 2020, it was reported that on an unspecified date, duragen was placed with onlay and inlay during an unknown procedure (craniotomy or endoscopic transscleral subretinal surgery).After the procedure, cerebrospinal fluid leakage was confirmed.No allegation of product malfunction was reported, and no further information was provided by the facility.
Additional Manufacturer Narrative
Duragen was not returned for evaluation (per customer, product not available) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.A medical assessment was requested and the following was concluded: ¿csf leak is a known complication of the procedure and a known complication of using duragen.No further information is available regarding patient status.Product was found acceptable and was not reported to have failed prior to clinical use.No further information was provided from the hospital and reported products will be not returned for analysis.¿ therefore, based on the information provided and the absence of a device for evaluation, a root cause determination is not possible at this moment.
Event or Problem Description
N/a.

• Brand Name: DURAGEN-UNKNOWN PRODUCT ID
• Common Device Name: PLAINSBORO
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• MDR Report Key: 10826596
• Report Number: 1121308-2020-00062
• Device Sequence Number: 3308155
• Product Code: GXQ
• Combination Product (Y/N): N
• PMA/510(K) Number: K982180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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 Catalogue Number: XXXDUR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1