BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMA INITIAL DRILL 1.8 X 11.5MM NON-IRRIGATED

    MDR report key: 2269408 · Received September 8, 2011

    Report

    Report Number
    3005990499-2011-00042
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Report Date
    August 11, 2011
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS STATED IN THIS REPORT'S EVENT DESCRIPTION, THE CLINICIAN REPORTED THAT THE DRILLING WAS PERFORMED THROUGH A METAL SLEEVE THAT WAS PLACED IN A SURGICAL GUIDE. THE TUBE AND SURGICAL GUIDE WERE PURCHASED BY THE COMPLAINANT FROM BIOHORIZONS IMPLANT SYSTEMS, INC, AND MAY NOT HAVE BEEN THE APPROPRIATE DIAMETER FOR THIS DRILL. THE METAL TUBE MAY HAVE BEEN TOO WIDE OR TOO NARROW; THIS COULD CAUSE BONDING OR A LOOSE FIT WHEN THE DRILL IS INSERTED, AND HAVE RESULTED IN THE DRILL FRACTURING. THIS CUSTOMER'S KEYSTONE DENTAL'S SALES REPRESENTATIVE IS SCHEDULING ADDITIONAL CUSTOMER IN-SERVICING TO ADVISE THIS CUSTOMER OF POTENTIAL PROBLEMS THAT MAY OCCUR WHEN USING COMPETITIVE BRAND TUBES AND SURGICAL GUIDES. TWO OTHER DRILLS THAT WERE USED DURING THIS PROCEDURE ALSO FRACTURED. PLEASE REFERENCE MEDWATCH NUMBERS 3005990499-2011-00041 AND 3005990499-2011-00043 FOR THE DETAILS OF THOSE DRILL FRACTURES. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. THIS PRODUCT IS SUPPLIED BY KEYSTONE DENTAL AS A NON-STERILE DEVICE, CONSEQUENTLY, THERE IS NO EXPIRATION DATE NOTED. THE LOT NUMBER OF THE DEVICE AT ISSUE IS NOT AVAILABLE; THEREFORE, THE MANUFACTURE DATE OF THE DEVICE IS UNKNOWN. ATTEMPTS WERE MADE TO OBTAIN DEVICE RETURN. A FOLLOW-UP MEDWATCH FORM WILL BE SUBMITTED IF THE DEVICE IS RECEIVED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THAT WHILE PREPARING OSTEOTOMY SITES FOR (B)(6) DURING A PATIENT'S (GENDER UNKNOWN) DENTAL PROCEDURE THE PRIMA INITIAL DRILL FRACTURED. THE CLINICIAN INDICATED THAT THE FRACTURE OCCURRED WHILE USING A BIOHORIZONS BRAND SURGICAL GUIDE, WITH THE DRILL INSIDE METAL DRILLING SLEEVES. THE CLINICIAN INDICATED THAT HE WAS ABLE TO SUCCESSFULLY REMOVE ALL PORTIONS OF THE DRILL FROM THE PATIENT'S MOUTH/THROAT MANUALLY USING HIS HANDS. IT WAS ALSO REPORTED THAT THE CLINICIAN SUCCESSFULLY PLACED THE DENTAL IMPLANTS DURING THIS PROCEDURE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE FRACTURED DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMA INITIAL DRILL 1.8 X 11.5MM NON-IRRIGATED NDP KEYSTONE DENTAL 15201 023175

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK