BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI CLICK'X LOCKING CAP FIR TI 3-D HEAD

    MDR report key: 2752162 · Received September 14, 2012

    Report

    Report Number
    8030965-2012-00787
    Event Type
    Injury
    Date Received
    September 14, 2012
    Report Date
    August 16, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWP
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PT DID NOT PROVIDE ANY INFO REGARDING REMOVAL OF HARDWARE OR REVISION SURGERY. 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.

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT THEY RECEIVED A CALL FROM THE PT. PT REPORTED THAT THE IMPLANTED RODS AND SCREWS BROKE OFF IN HIS BACK AND CAUSED INJURY. THE PT WOULD NOT PROVIDE ANY ADD'L INFO REGARDING HIS INITIAL SURGERY, ANY SUBSEQUENT SURGERY, OR MEDICAL CONDITION. HOSPITAL REPORTED PT HAD SURGERY ON (B)(6) 2007. PT WAS IMPLANTED WITH 11 SCREWS, 11 LOCKING CAPS, 10 HEADS FOR SCREWS, TWO 6 MM RODS. SYNTHES WAS INFORMED THAT THE HOSPITAL WILL BE SUBMITTING MEDWATCH. SYNTHES HAS NOT RECEIVED MEDWATCH AS OF THIS DATE. THIS IS 4 OF 36 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI CLICK'X LOCKING CAP FIR TI 3-D HEAD TI CLICK'X LOCKING CAP KWP SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOCKING CAPS| SCREWS| RODS| HEADS| TRANSCONNECTOR