BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING DRILL EXTENDER

    MDR report key: 1592963 · Received January 29, 2010

    Report

    Report Number
    3005990499-2010-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2010
    Date of Event
    January 1, 2009
    Report Date
    November 11, 2009
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED PART CONFIRMS THE DRILL EXTENDER IS BROKEN. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE IS CORROSION, AND NORMAL WEAR AND TEAR. THE DEVICE WAS USED AT LEAST (30) TIMES. KEYSTONE DENTAL INC. ALSO DETERMINED THAT THIS CUSTOMER PURCHASED THE DEVICE IN MARCH OR JULY OF 2008. KEYSTONE DENTAL'S SURGICAL MANUAL RECOMMENDS DRILLS BE REPLACED WHEN WORN, CORRODED, DULL OR OTHERWISE COMPROMISED. FURTHER, THAT DRILLS SHOULD BE REPLACED AFTER APPROXIMATELY TWENTY (20) USES DEPENDING ON BONE DENSITY. IT IS LEFT TO THE PHYSICIAN TO TRACK INDIVIDUAL DEVICE USAGE. IT IS CONCLUDED THAT KEYSTONE DENTAL LABELING INSTRUCTIONS ON HOW THE PRODUCT MAY BE USED SAFELY TO AVOID THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE OSSEOTOMY PROCEDURE, THE LOCKING DRILL EXTENDER FRACTURED (IMPLANT SITE NUMBER UNKNOWN). THERE WAS NO PATIENT INTERVENTION OR ADVERSE EFFECTS. THE CUSTOMER DOES NOT KNOW THE LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING DRILL EXTENDER DZA KEYSTONE DENTAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1