BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP DRIVER LATCH SHORT 5.5/6.5 IMP

    MDR report key: 2194905 · Received July 21, 2011

    Report

    Report Number
    3005990499-2011-00034
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 23, 2011
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    MICROSCOPIC EXAMINATION OF THE RETURNED IMPLANT REVEALED MARKINGS ON THE EXTERNAL THREADS OF THE IMPLANT, LIKELY CAUSED BY A CLAMPING INSTRUMENT DURING REMOVAL OF THE DRIVER FROM THE IMPLANT. THE INTERNAL FEATURE OF THE IMPLANT WAS SEVERELY DEFORMED, ALTHOUGH IT'S UNCERTAIN WHAT CAUSED THIS. THERE WAS VERY MINOR DEFORMATION OF THE LOBES WHERE THE DRIVER ENGAGES THE IMPLANT. THIS IS EXPECTED WITH NORMAL USE. MICROSCOPIC EXAMINATION OF THE RETURNED DRIVER REVEALED SEVERE DEFORMATION OF THE TYPE-1 SHANK AT THE END WHERE IT FITS INTO A HANDPIECE/ADAPTER. THE DEFORMATION WAS MORE SUBSTANTIAL IN THE COUNTER-CLOCKWISE DIRECTION AND WAS MORE THAN SEEN IN TYPICAL USE. THERE WERE MARKINGS ON THE SHAFT LIKELY CAUSED BY A CLAMPING INSTRUMENT DURING REMOVAL OF THE DRIVER FROM THE IMPLANT. THERE WAS A SMALL AMOUNT OF RESIDUE ON THE LOBE REGION, WHICH IS A NORMAL FINDING. THERE WAS A SURFACE FINISH DIFFERENCE ON THE DRIVER WHERE IT ENGAGES THE IMPLANT, WHICH IS EXPECTED FROM CONTACT BETWEEN TWO METAL COMPONENTS. IT IS LIKELY THE INTENDED FRICTION FIT BETWEEN THE DRIVER AND IMPLANT IN COMBINATION WITH AN EXCESSIVE AXIAL PRESSURE APPLIED BY THE CLINICIAN RESULTED IN A HIGH RETENTION FORCE MAKING DRIVER REMOVAL DIFFICULT. THIS PRODUCT IS SUPPLIED BY KEYSTONE DENTAL AS A NON-STERILE DEVICE, CONSEQUENTLY, THERE IS NO EXPIRATION DATE. THE LOT NUMBER OF THE DEVICE AT ISSUE IS NOT AVAILABLE; THEREFORE, THE MANUFACTURE DATE OF THE DEVICE IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE CLINICIAN ATTEMPTED TO PLACE THE IMPLANT IN A PATIENT (AGE AND GENDER UNKNOWN), BUT THE IMPLANT DRIVER BECAME STUCK TO THE IMPLANT (FDI DENTAL SITE UNKNOWN). THERE WAS NO INDICATION FROM THE COMPLAINANT OF ANY ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE REPORTED PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMP DRIVER LATCH SHORT 5.5/6.5 IMP NDP KEYSTONE DENTAL G21272 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK