BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMI SURGICAL PRODUCTS

    MDR report key: 724112 · Received May 18, 2006

    Report

    Report Number
    MW1039266
    Event Type
    Injury
    Date Received
    May 18, 2006
    Date of Event
    May 12, 2006
    Report Date
    May 18, 2006
    Manufacturer
    SM USA INC
    Product Code
    HBL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS BEING POSITIONED FOR A POSTERIOR CERVICAL LAMINECTOMY (C4-5, C6-7). THE MAYFIELD HEAD CLAMP WITH PINS SLIPPED AND CAUSED A SMALL CUT AT THE INSERTION SITE ON THE LEFT SIDE OF THE HEAD. THE PHYSICIAN CLIPPED THE CUT AND REPOSITIONED ANOTHER HEAD CLAMP AND PINS AND PROCEEDED WITH THE PROCEDURE. REASON FOR OCCURRENCE IS DIFFICULT. INSPECTION OF CLAMP SHOWED NO WEAKNESSES. THE LOCK MAY NOT HAVE BEEN COMPLETELY FASTENED OR THE PINS MAY NOT HAVE BEEN IN THE SKULL AS SECURELY AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMI SURGICAL PRODUCTS MODIFIED MAYFIELD SKULL CLAMP HBL SM USA INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR