BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PLATE, MP, 16 HOLE

    MDR report key: 6946279 · Received October 12, 2017

    Report

    Report Number
    0008010177-2017-00260
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 1, 2017
    Report Date
    March 19, 2018
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED SEVERAL TIMES, BUT NO FURTHER INFORMATION REGARDING THE USED BLADE RESPECTIVELY DRILL BIT COULD BE ACQUIRED. THE SALES REPRESENTATIVE HAS UPLOADED AN X-RAY INTO TRACKWISE ABOUT THE PRODUCT COMPLAINT. THE IMAGE HAS BEEN ATTACHED IN THIS REPORT AND SHOWS THE BROKEN PLATE. FURTHER, AN OPINION FROM STRYKER¿S SR GLOBAL MEDICAL DIRECTOR HAS BEEN REQUESTED. ALL COMPLAINT DETAILS WERE FORWARDED TO HIM FOR ASSESSMENT. HE STATED: IT LOOKS LIKE THE POSTERIOR SCREW HOLE IS TOO CLOSE TO THE FRACTURED EDGE. THIS COULD HAVE RESULTED IN SOME MICRO-MOTION AND TORQUE ON THE PLATE OVER THE FRACTURE, RESULTING IN BREAKAGE. DOCUMENTED BY SR GLOBAL MEDICAL DIRECTOR, FOR (B)(4) ON (B)(6) 2017. THEREFORE MOST LIKELY THE ROOT CAUSE IS ATTRIBUTED TO A NONCOMPLIANT USAGE. BASED ON STATISTICAL EVALUATION THERE ARE NO INDICATIONS FOR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. THEREFORE NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND. IF THE COMPLAINED DEVICE WILL BE RETURNED AT A LATER DATE, THE COMPLAINT INVESTIGATION WILL BE REOPENED. DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A PLATE THAT HAD FRACTURED POST OPERATIVELY. THE PATIENT WILL UNDERGO A REVISION SURGERY TO REPLACE THE FRACTURED PLATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A PLATE THAT HAD FRACTURED POST OPERATIVELY. THE PATIENT WILL UNDERGO A REVISION SURGERY TO REPLACE THE FRACTURED PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722892 BONE PLATE, MP, 16 HOLE IMPLANT JEY STRYKER LEIBINGER FREIBURG NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1