BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XR2 METAL-FREE CONVERSION ADAPTOR

    MDR report key: 3893598 · Received June 9, 2014

    Report

    Report Number
    3004608878-2014-00085
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    K130389
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE SKULL CLAMP FROM THE PATIENT AFTER THE SURGERY, THE METAL FREE CONVERSION ATTACHMENT WOULD NOT RELEASE. AFTER SEVERAL ATTEMPTS, A SURGICAL INSTRUMENT WAS USED TO RELEASE THE PISTON HOLDING THE PIN. THE SAPPHIRE PIN THAT WAS USED IN THE SURGERY CRACKED AND THE TIP BROKE OFF. THE VERY TIP OF THE PIN COULD STILL BE IN THE PATIENT SKULL. THE SURGEON AND STAFF COULD NOT VERIFY. ADDITIONAL INFORMATION WAS REQUESTED AND ON (B)(6) 2014, THE FOLLOWING WAS REPORTED BY THE SALES REPRESENTATIVE: ON (B)(6) 2014, A (B)(6) YEAR OLD MALE PATIENT UNDERWENT A CRANIOTOMY FOR TUMOR REMOVAL. SURGICAL PLIER WAS THE SURGICAL INSTRUMENT USED TO RELEASE THE PISTON HOLDING THE PIN. THE THREE ADULT SAPPHIRE PINS USED IN THE SURGERY WERE THE A2020 (MAYFIELD RADIOLUCENT SKULL PINS). LOT NUMBER OF THE PINS WERE NOT KNOWN. IT WAS CONFIRMED THAT THE TIP OF THE PIN WAS LIKELY STILL IN THE PATIENT SKULL. NO PATIENT TREATMENT WAS DONE. IT WAS REPORTED THAT MOST LIKELY, THE SURGEON WILL REMOVE THE PIN IF IT DOES NOT WORK ITSELF OUT EVENTUALLY OR IF IT CAUSES ADDITIONAL PROBLEMS. IF THEY STILL HAVE IT, THE BROKEN PIN WILL POTENTIALLY BE RETURNED TO INTEGRA FOR EVALUATION. THE XR2 METAL FREE CONVERSION ADAPTOR WILL BE SENT BACK TO INTEGRA NEXT WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334302 XR2 METAL-FREE CONVERSION ADAPTOR NEURO HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other A2020 (MAYFIELD RADIOLUCENT SKULL PINS)