BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-06205

    MDR report key: 3329102 · Received September 6, 2013

    Report

    Report Number
    2520274-2013-06205
    Event Type
    Injury
    Date Received
    September 6, 2013
    Date of Event
    September 5, 2012
    Report Date
    August 8, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS RECEIVED ENTITLED, WHICH IMPLANT IS BEST AFTER FAILED TREATMENT FOR PATHOLOGIC FEMUR FRACTURES? BY JONATHAN AGNER FORSBERG MD, RIKARD WEDIN MD, PHD, HENRIK BAUER MD, PHD, CLIN ORTHOP RELAT RES (2013) 471:735¿740. THIS STUDY EVALUATED PATIENTS WITH FEMORAL METASTASES IN WHOM IMPLANTS FAILED. EIGHTY EIGHT (88) PATIENTS WHO UNDERWENT SALVAGE PROCEDURES WERE STUDIED. THESE INCLUDED 11 PATIENTS WITH INTRAMEDULLARY NAILS. IT WAS REPORTED THAT 5 PATIENTS REQUIRED REOPERATION DUE TO FAILURE OF THE SALVAGE IMPLANT WITH THE MOST COMMON CAUSES FOR REOPERATION ACROSS ALL TREATMENT GROUPS BEING MATERIAL FAILURE, LOCAL PROGRESSION OF THE TUMOR OR A COMBINATION OF THESE. FURTHER POSTOPERATIVE COMPLICATIONS ACROSS ALL TREATMENT GROUPS INCLUDED DISLOCATION, SUPERFICIAL WOULD INFECTIONS AND SYSTEMIC ILLNESS OR A COMBINATION OF THESE. THE ARTICLE DID NOT IDENTIFY COMPLICATIONS ACCORDING TO SPECIFIC IMPLANT. IT IS UNKNOWN IF THIS IS A SYNTHES PRODUCT. THIS REPORT IS FOR AN UNKNOWN AMOUNT OF NAIL(S). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443008 LXT SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention