BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEIN DENTAL ELEVATOR, 2MM, STRAIGHT

    MDR report key: 5021837 · Received August 21, 2015

    Report

    Report Number
    0008010177-2015-00208
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 15, 2015
    Manufacturer
    STRYKER LEIBINGER FREIBURG (MDR)
    Product Code
    LRC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT THE TIP OF THE DEVICES HAVE BENT COULD BE CONFIRMED. THE VISUAL EXAMINATION REVEALED THAT THE TIPS OF THE DEVICES ARE BENT COMPARED TO THEIR ORIGINAL SHAPE AND SHOW DEFORMATIONS DUE TO MECHANICAL OVERLOAD. BOTH THE DHR REVIEW AND THE HARDNESS MEASUREMENTS PERFORMED SHOWED THAT THE DEVICES WERE MANUFACTURED ACCORDING TO SPECIFICATION. MOST LIKELY TOO HIGH BENDING FORCES WERE APPLIED TO THE TIP DURING USAGE, LEADING TO A DEFORMATION. THEREFORE THE ROOT CAUSE CAN BE TIED TO A USER RELATED ISSUE. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER REPRESENTATIVE THAT HE HAD A CUSTOMER STATING VIA EMAIL THAT THEY PURCHASED 7 ELEVATORS FROM STRYKER TO USE IN THEIR ORAL SURGERY DEPARTMENT, WHICH OPENED FOR BUSINESS LESS THAN A YEAR AGO; THE PRODUCT NUMBER ON THEM IS CE 09-23201, AND ALL OF THEIR TIPS HAVE EITHER BENT, CHIPPED OR BROKEN DURING USE. UPON INVESTIGATION IT WAS NOTED THAT 6 ELEVATORS WERE PURCHASED OVER A YEAR AGO. IN (B)(6) 2015, (B)(4) WAS ISSUED FOR 2 UNITS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER REPRESENTATIVE THAT HE HAD A CUSTOMER STATING VIA EMAIL THAT THEY PURCHASED 7 ELEVATORS FROM STRYKER TO USE IN THEIR ORAL SURGERY DEPARTMENT, WHICH OPENED FOR BUSINESS LESS THAN A YEAR AGO; THE PRODUCT NUMBER ON THEM IS CE 09-23201, AND ALL OF THEIR TIPS HAVE EITHER BENT, CHIPPED OR BROKEN DURING USE. UPON INVESTIGATION IT WAS NOTED THAT 6 ELEVATORS WERE PURCHASED OVER A YEAR AGO. IN (B)(6) 2015, PR# (B)(6) WAS ISSUED FOR 2 UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555185 BEIN DENTAL ELEVATOR, 2MM, STRAIGHT INSTRUMENT LRC STRYKER LEIBINGER FREIBURG (MDR) AD03

    Patients

    Seq Age Sex Outcome Treatment
    1