BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 38MM

    MDR report key: 3619135 · Received February 10, 2014

    Report

    Report Number
    2520274-2014-00476
    Event Type
    Injury
    Date Received
    February 10, 2014
    Report Date
    January 22, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). COMMON DEVICE NAME: KTT. IMPLANT DATE: ELEVEN MONTHS AGO. (B)(4). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT WAS IMPLANTED WITH DEVICES 11 MONTHS AGO FOR TREATMENT OF A HIGH ENERGY OPEN PILON FRACTURE OF THE RIGHT DISTAL TIBIA. DURING A POST OPERATIVE VISIT, IT WAS DETERMINED THAT THERE WAS AN INFECTION AT THE FRACTURE SITE. THE SURGEON PROCEEDED WITH HARDWARE REMOVAL ON (B)(6) 2014. ALL HARDWARE WAS REMOVED AND NO FURTHER PROCEDURES OCCURRED DURING THE EXPLANT. IT WAS REPORTED THAT THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 2 OF 16 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86931 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 38MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention