BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2012-03652

    MDR report key: 2862049 · Received December 7, 2012

    Report

    Report Number
    2520274-2012-03652
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    April 27, 2010
    Manufacturer
    SYNTHES
    Product Code
    UNK
    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. THE EXACT PART NUMBER COULD NOT BE IDENTIFIED. PRODUCT CODES FOR THIS REPORT WERE UNKNOWN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE WAS NOT RETURNED TO MANUFACTURING. 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 LOOSENING OF AN IMPLANT WAS DETECTED. THE PATIENT WAS INITIALLY FREE OF PAIN. AFTERWARDS, A LOOSENING OF THE IMPLANT WAS DETECTED. STABILIZATION WAS PERFORMED LATER IN ANOTHER CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention