BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALCOLM RAND PINS

    MDR report key: 435823 · Received December 31, 2002

    Report

    Report Number
    435823
    Event Type
    Injury
    Date Received
    December 31, 2002
    Date of Event
    November 26, 2002
    Report Date
    December 10, 2002
    Manufacturer
    CMI/ELEKTA INSTRUMENTS, INC.
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING CRANIOTOMY FOR AV MALFORMATIONS. RADIOLUCENT HEAD-HOLDER FAILED INTRAOPERATIVELY.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 5/20/03: ELEKTA INSTRUMENTS, INC IS NOT THE MFR OF THIS PRODUCT BUT WAS FORMERLY A DISTRIBUTOR. ELEKTA INSTRUMENTS, INC. HAS NOT DISTRIBUTED THIS PRODUCT SINCE 1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALCOLM RAND PINS TITANIUM HEAD FIXATION PIN TIPS HBL CMI/ELEKTA INSTRUMENTS, INC. * 0619704

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R