BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP RECOPL 3.5 STRAIGHT W/COMBINED HOLE

    MDR report key: 2870500 · Received December 12, 2012

    Report

    Report Number
    2520274-2012-03775
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 15, 2010
    Report Date
    December 20, 2010
    Manufacturer
    SYNTHES
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:(B)(4): IT WAS REPORTED AN X-RAY WAS TAKEN. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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

    EU COMPLAINT HANDLING UNIT REPORTED A PLATE BROKE POST-OPERATIVELY. THE PATIENT FELL DOWN AND BROKE HIS CLAVICLE. HE HAD SURGERY WITH LOCKING COMPRESSION RECONSTRUCTION PLATE, 9 HOLES ON (B)(6) 2010. AFTER FOUR MONTHS, HE BROKE HIS BONE AGAIN AFTER LIFTING SOMETHING HEAVY. HE HAD REVISION SURGERY WITH A USE OF LOCKING COMPRESSION PLATE, 10 HOLES. AFTER THE SURGERY, THE REDUCTION WAS NOT SUFFICIENT, DUE TO A SMALL GAP ACCORDING TO AN X-RAY. THE PATIENT MIGHT HAVE HAD THE NON-UNION DUE TO THIS GAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP RECOPL 3.5 STRAIGHT W/COMBINED HOLE LCP RECOPL 3.5 STRAIGHT W/COMBINED HOLE KTT SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention