BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USS-SMALL STAT/PAED-ROD Ø5 HARD L300 TI

    MDR report key: 2928765 · Received January 24, 2013

    Report

    Report Number
    2530088-2013-00077
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 26, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HSB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS FOR PART NUMBER 498.239, USS SMALL STATURE PAED ROD, AND THE RAW MATERIAL LOT NUMBER 4211791 SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH THE SPECIFICATION AND WITHIN THE INTERNATIONAL STANDARD. AS NO DETAILED CLINICAL INFORMATION IS AVAILABLE, WE CAN ONLY ASSUME THAT THE ROD BROKE OF DUE TO MECHANICAL OVERLOAD, CLEARLY VISIBLE ON THE X-RAYS. THE BROKEN SURFACE IT SELVES IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY AS WELL. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT SUFFERED A LATERAL LEFT ROD FRACTURE IN THE LEVEL TH12. THE FRACTURED ROD WAS RETRIEVED AND IT WASN'T REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34880 USS-SMALL STAT/PAED-ROD Ø5 HARD L300 TI USS-SMALL STAT/PAED-ROD HSB SYNTHES BRANDYWINE 5633312

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention ROD, SCREW