BEUDAMED
    FDA Adverse Event Injury Summary report: N

    135 DEG TI LC-DHS® PLATE- STANDARD BARREL 4 HOLES/78MM

    MDR report key: 2851952 · Received November 29, 2012

    Report

    Report Number
    2520274-2012-03485
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    June 8, 2009
    Report Date
    August 5, 2009
    Manufacturer
    SYNTHES
    Product Code
    JDO
    PMA / PMN Number
    K953607
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(6) COMPLAINT HANDLING UNIT REPORTED A DYNAMIC HIP AND CONDYLAR SCREW BROKE. ON (B)(6) 2009, IT WAS REPORTED AFTER THE PATIENT WALKED UP THE STAIRS, THE PATIENT HAD A COLLUM FRACTURE IN THE RIGHT LEG, ABOVE THE GREATER TROCHANTER. THERE WAS NO EVIDENCE FOR PATHOLOGIC CAUSE. PLACEMENT OF THE DYNAMIC HIP SCREW PLATE WAS ON (B)(6) 2009, AND IN GOOD POSITION. CALLUS FORMATION AND SOME DYNAMISATION OF DYNAMIC HIP SCREW WAS OBSERVED ON (B)(6) 2009. THE IMPLANT WAS OBSERVED TO BE IN GOOD POSITION WITH THE SAME DYNAMISATION ON (B)(6) 2009. ON (B)(6) 2009 THE DYNAMIC HIP AND CONDYLAR SCREW BROKE. ON (B)(6) 2009 THE BROKEN DYNAMIC HIP AND CONDYLAR SCREW WAS REMOVED AND REPLACED WITH AN EXTRA CANNULATED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 135 DEG TI LC-DHS® PLATE- STANDARD BARREL 4 HOLES/78MM 135 DEG TI LC-DHS® JDO SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention