BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL LOCK-PL 2.4 STRAIG 20HO TI

    MDR report key: 2880041 · Received December 19, 2012

    Report

    Report Number
    2520274-2012-04200
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    August 17, 2010
    Report Date
    August 26, 2010
    Manufacturer
    SYNTHES
    Product Code
    HRS
    PMA / PMN Number
    K093772
    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. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HWC. IMPLANT DATE IN (B)(6) 2008. EXACT DATE UNKNOWN. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 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

    THE (B)(6) COMPLAINT HANDLING UNIT REPORTED THAT THE TWO PLATES WERE BROKEN POST-OPERATIVELY. THE INITIAL SURGERY WAS IN (B)(4) 2008 AND THE PATIENT WAS TREATED WITH THREE STERNAL LOCKING PLATES 2.4 AND ONE STERNAL LOCKING H-PLATE 2.4. IN (B)(4) 2009, THE X-RAYS TAKEN SHOWED NO ABNORMALITIES, THEN THE PATIENT HAD PAIN ON AN UNKNOWN DATE AND THE X-RAYS TAKEN THEN SHOWED THAT TWO PLATES WERE BROKEN. THE IMPLANTS WERE REMOVED ON (B)(4) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERNAL LOCK-PL 2.4 STRAIG 20HO TI STERNAL LOCKING PLATE HRS SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention