BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE ANGLED CLAMP

    MDR report key: 3170697 · Received June 14, 2013

    Report

    Report Number
    1723170-2013-00440
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K990214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED REPORT FOR 3 FIELDS ONLY:BRAND NAME CORRECTED TO READ: OPEN SPINE ANGLED CLAMP,CATALOG NUMBER CORRECTED TO READ: 9730026,510(K) CORRECTED TO: K990214,ALL OTHER INFORMATION ON INITIAL REPORT IS CORRECT AND REMAINS THE SAME.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. DEVICE MANUFACTURING DATE IS UNAVAILABLE AT THE TIME OF THIS REPORT. RMA ISSUED. REPLACEMENT OPEN SPINE CLAMP SHIPPED TO SITE (B)(4) 2013. MEDTRONIC EVALUATION OF RETURNED SUSPECT DEVICE FINDS THE ADJUSTMENT SCREW THREADS ARE DAMAGED IN THE AREA THAT PASSES THROUGH THE CYLINDER. THE THREADS ARE WORN DOWN AND SLIPPING. ALSO, THE CYLINDER IS CRACKED ON THE TOP AND BOTTOM SIDE OF THE CYLINDER, BROKEN ALL THE WAY THROUGH ON THE TOP SIDE. THE HEAD OF THE ADJUSTMENT SCREW HAS TOOL MARKS AROUND THE OUTSIDE EDGE. THE RETAINER RING IS STRETCHED FROM OVERTIGHTENING AND ALLOWS SOME PLAY OF THE CLAMP FACE. THE PHYSICAL DAMAGE, BROKEN PIECES, DIRECTLY CAUSED THE EVENT.

    Additional Manufacturer Narrative · 1

    RECEIVED MANUFACTURE DATE 10/2003 (MONTH AND YEAR ONLY). E-SUB TOOL FORCES DAY DATE SO PLEASE DISREGARD "01" ENTERED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, PURCHASING, REPORTED AN ANGLED SPINE CLAMP THAT WAS DAMAGED AT THE POINT WHERE THE SCREW GOES IN, APPEARS TO BE SPLIT. THIS ISSUE WAS IDENTIFIED WHILE IN STERILE PROCESSING. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270980 OPEN SPINE ANGLED CLAMP NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 179316

    Patients

    Seq Age Sex Outcome Treatment
    1