BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LCP® PLATE 8 HOLES 111MM

    MDR report key: 2840903 · Received November 20, 2012

    Report

    Report Number
    2520274-2012-03266
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    February 28, 2009
    Report Date
    March 19, 2009
    Manufacturer
    SYNTHES
    Product Code
    HRS
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. 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

    (B)(6) COMPLAINT HANDLING UNIT REPORTED A PLATE BROKE POST-OPERATION. THE PATIENT HAD AN ULNA WEDGE FRACTURE WHICH REQUIRED SURGICAL OPERATION WITH USE OF AN LC-LCP PLATE SMALL 8 HOLES, ON (B)(6) 2008. HE WAS IMMOBILIZED IN A CAST FOR TEN DAYS AND THEN HE WAS ALLOWED TO MAKE FREE ACTION LIKE EXTENSION AND INFLECTION. HE SAID THAT HE DID NOT LIFT THE HEAVY STUFF. THE PATIENT FELT PAIN AND VISITED THE HOSPITAL AGAIN ON (B)(6) 2009. THE DOCTOR TOOK AN X-RAY AND FOUND THAT THE PLATE WAS BROKEN. REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2009 AND REPLACED WITH A LC-LCP PLATE, SMALL 10 HOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM TI LCP® PLATE 8 HOLES 111MM 3.5MM TI LCP® PLATE HRS SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention