BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI CLICK'X® LOCKING CAP FOR TI 3-D HEAD

    MDR report key: 6088031 · Received November 8, 2016

    Report

    Report Number
    2520274-2016-15303
    Event Type
    Injury
    Date Received
    November 8, 2016
    Report Date
    October 11, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: EVENT DATE: UNKNOWN. ADDITIONAL DEVICE PRODUCT CODES ARE MNI, MNH, KWP, AND KWQ. (B)((4). IT WAS NOT REPORTED THAT THIS DEVICE WAS EXPLANTED DURING THE SEP 13, 2016 REVISION SURGERY. THIS DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR INVESTIGATION. (B)((6). REASON FOR REVISION SURGERY (PAIN) AND WAS NOT REPORTED TO MANUFACTURER UNTIL OCT 18, 2016. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DATE OF MANUFACTURE IS UNKNOWN. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTED AN EVENT IN (B)((6) AS FOLLOWS: IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)((6) 2016 DUE TO POSTOPERATIVE PAIN. THE PATIENT WAS INITIALLY IMPLANTED WITH TWO (2) 6.0MM CURVED RODS, TWO (2) 7.0MM CLICK'X PEDICLE SCREWS 40MM LENGTH, TWO (2) 6.2MM PEDICLE SCREWS 45MM LENGTH, SIX (6) CLICK'X LOCKING CAPS FOR 3-D HEADS, FOUR (4) 3-D HEADS FOR CLICK'X SCREWS, TWO (2) 6.2MM CLICK'X PEDICLE SCREWS PREASSEMBLED 40MM, AND CHRONOS PUTTY ON (B)((6) 2011. THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION AND NONE OF THE ORIGINAL DEVICES WERE REPORTEDLY REMOVED DURING THE (B)((6) 2016 REVISION SURGERY. DURING THE SURGERY THE SURGEON EXTENDED THE ORIGINAL CONSTRUCT. RELATED COMPLAINT, (B)((4), ADDRESSES AND REPORTS AN ADDITIONAL EVENT ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 9 OF 19 FOR (B)((4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737003 TI CLICK'X® LOCKING CAP FOR TI 3-D HEAD ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention