BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURAWRAP NERVE PROTECTOR 10MM ID X 4CM LENGTH

    MDR report key: 1654363 · Received April 7, 2010

    Report

    Report Number
    1121308-2010-00009
    Event Type
    Other
    Date Received
    April 7, 2010
    Date of Event
    March 16, 2010
    Report Date
    April 7, 2010
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    JXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PATIENT HAD SURGERY FOR TRANSPOSITION OF THE ULNAR NERVE. A REVISION SURGERY WAS REQUIRED SUBSEQUENTLY, AND WAS DONE ON (B)(6) 2009. DURING THE REVISION SURGERY, THE PRODUCT WAS IMPLANTED AS INDICATED TO PROTECT THE PERIPHERAL NERVE. ABOUT FOUR MONTHS AFTER THE SURGERY, DURING WHICH THE NEURAWRAP WAS USED, THE PATIENT DEVELOPED AN INFLAMMATORY RESPONSE WITH SWELLING AT THE SURGICAL SITE. A FURTHER EXPLORATORY SURGERY WAS DONE DURING WHICH IT WAS DETERMINED THAT THERE WAS BLOOD AT THE SURGICAL SITE; THIS WAS CONSIDERED TO BE THE CAUSE OF THE SWELLING. THE IMPLANTED PRODUCT WAS COMPLETELY INTACT AND THE SURGEON DID NOT CONSIDER THAT IT WAS RELATED TO THE WOUND SITE INFLAMMATION. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURAWRAP NERVE PROTECTOR 10MM ID X 4CM LENGTH NEURAWRAP JXI INTEGRA LIFESCIENCES CORPORATION 1092089

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention