BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT PLUS FORCEPS

    MDR report key: 6182909 · Received December 16, 2016

    Report

    Report Number
    2515379-2016-00029
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Report Date
    January 25, 2017
    Manufacturer
    DENTSPLY CAULK
    Product Code
    DZN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    RIGHT TIP HAS BROKEN OFF. FRACTURE SURFACE SHOWS SIGNS OF CORROSION WELL ACROSS THE SURFACE WHICH INDICATES THERE WAS LIKELY A CRACK IN THE BENT AREA FOR SOME TIME BEFORE THE BREAKAGE. THE LEFT TIP IS STILL INTACT BUT IT ALSO HAS A CRACK IN THE BEND WHICH WOULD ALSO HAVE FAILED SOON. INCORRECT MANUFACTURE OF THE TIP AREA IS THE MOST LIKELY CAUSE OF THE INITIAL CRACKING WHICH ULTIMATELY LEADS TO THE BREAKAGE. A SCAR HAS BEEN ISSUED TO THE ORIGINAL MANUFACTURER TO CORRECT THIS ISSUE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PAIR OF PALODENT PLUS FORCEPS BROKE AT THE TIP; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834071 PALODENT PLUS FORCEPS INSTRUMENTS, DENTAL HAND DZN DENTSPLY CAULK NA A1213

    Patients

    Seq Age Sex Outcome Treatment
    1