BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY RECONSTRUCTION PLATE, RIGHT

    MDR report key: 3830579 · Received May 23, 2014

    Report

    Report Number
    0008010177-2014-00136
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K014263
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED ACCORDING TO THE X-RAY PROVIDED. A VISUAL, FUNCTIONAL AND DIMENSIONAL EXAMINATION CANNOT BE PERFORMED AND IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE. ACCORDING TO THE RELATED DESIGN RISK ANALYSIS THERE ARE THESE POSSIBLE ROOT CAUSES: WRONG/ MISSING INFORMATION; TOO MUCH LOAD ON IMPLANT / BONE (E.G. DUE TO TMJ DISORDER/DISEASE); IMPROPER INSERTION/ POSITIONING OF IMPLANT; ABNORMAL MENTAL/ PHYSIOLOGICAL CONDITION OF PATIENT; WRONG IMPLANT PLACEMENT (E.G. REGION WITH REDUCED BONE QUALITY, TOO MUCH BONE COMPRESSION DURING SCREW INSERTION); IMPLANT WAS DAMAGED BY INSTRUMENT/SCREW DURING BENDING/SHAPING/INSERTION; WRONG CHOICE OF IMPLANT (E.G. SCREW TOO SHORT DUE TO SYSTEM MIX-UP AND / OR POORLY ASSEMBLED/USED INSTRUMENT OR MISLEADING MEASURING/IDENTIFICATION). IF THE PRODUCT WILL BE RETURNED AT A LATER DATE AN APPROPRIATE INVESTIGATION WILL BE PERFORMED, THE COMPLAINT WILL BE RE-OPENED AND THE RESULT REVISED. SALES REP MOVED TERRITORIES AND IN THE TRANSITION, THE DEVICE WAS MISPLACED AND THEREFORE, NOT RETURNED.

    Description of Event or Problem · 1

    ORIGINAL CASE OCCURED ONE AND HALF TO TWO MONTHS AGO. THE PATIENT REPORTED THAT THEY WERE SLEEPING ON THE SIDE OF THE FACE WHERE THE PLATE HAD BEEN IMPLANTED AND HEARD A POPPING NOISE UPON WAKING UP. ON (B)(6) 2014 A SCAN WAS PERFORMED AND THEY DISCOVERED THAT THE PLATE HAD BROKEN.

    Description of Event or Problem · 1

    ORIGINAL CASE OCCURED ONE AND HALF TO TWO MONTHS AGO. THE PATIENT REPORTED THAT THEY WERE SLEEPING ON THE SIDE OF THE FACE WHERE THE PLATE HAD BEEN IMPLANTED AND HEARD A POPPING NOISE UPON WAKING UP. ON (B)(6) 2014 A SCAN WAS PERFORMED AND THEY DISCOVERED THAT THE PLATE HAD BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308369 PRIMARY RECONSTRUCTION PLATE, RIGHT IMPLANT JEY STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1