BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM VA-LOCKING CALCANEAL PLATE SMALL 58MM LEFT

    MDR report key: 4112688 · Received September 24, 2014

    Report

    Report Number
    2520274-2014-13792
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    PK131186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.ADDITIONAL INFORMATION, NOT CAPTURED ON PREVIOUS INITIAL REPORT.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO IMPLANT THE VA LCP 2.7MM CALCANEAL VA LOCKING PLATE, THE SURGEON REPORTS THE LEFT CALCANEOUS FRACTURE DISPLACED A BIT WHEN THE METAPHYSEAL SCREW WAS TIGHTENED DOWN TO THE PLATE. THIS IS FROM VA LCP 2.7MM AND 3.5MM MIDFOOT/HINDFOOT SYSTEM MPE 30. THIS IS REPORT NUMBER 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    THE FRACTURE WAS DISPLACED WHEN THE SCREW WAS TIGHTENED TO THE PLATE EVEN WITH 3 WIRES IN PLACE. THE PROCEDURE HAD EXTENDED OPERATIVE TIME OF GREATER THAN 14 MINUTES AND LESS THAN 30 MINUTES DUE TO DEVICE RELATED REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596186 2.7MM VA-LOCKING CALCANEAL PLATE SMALL 58MM LEFT PLATE,FIXATION,BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR