BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 5653786 · Received May 13, 2016

    Report

    Report Number
    2520274-2016-12680
    Event Type
    Injury
    Date Received
    May 13, 2016
    Report Date
    April 27, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. THIS REPORT IS FOR TWO (2) UNKNOWN CLICK-X RODS. (OTHER): WITHOUT A VALID PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. THE ORIGINAL IMPLANT PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. THE COMPLAINANT PARTS ARE NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). USED TO REPORT THE PATIENT¿S ADJACENT LEVEL DISK DISEASE. AS SPECIFIC PART AND LOT NUMBERS FOR THE COMPLAINANT CLICK-X DEVICES WERE NOT PROVIDED. HOWEVER, THE LIKELY 510K BASED ON THE TYPE OF CONSTRUCT IS K031175. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS ORIGINALLY IMPLANTED AT L4-S1 DISC LEVELS ON AN UNKNOWN DATE WITH A CLICK-X CONSTRUCT THAT INCLUDED: TWO (2) RODS, SIX (6) SCREWS, AND SIX (6) LOCKING CAPS. ON (B)(6) 2016, THE PATIENT WAS REVISED DUE TO ADJACENT LEVEL SEGMENT DISEASE AT L2-L3. DURING THE REVISION SURGERY, THE SURGEON REMOVED ALL SIX (6) CLICK-X LOCKING CAPS AND THE TWO (2) CLICK-X RODS. THE ORIGINAL SIX (6) SCREWS WERE LEFT IN THE PATIENT. THEN, THE SURGEON IMPLANTED COMPETITOR'S SCREWS AT L2-L3 AND NEW RODS (COMPETITOR'S) AT L2- S1. FINALLY, COMPETITOR'S LOCKING CAPS WERE PLACED AT L2-L3 WITH NEW CLICK-X LOCKING CAPS, WHICH WERE IMPLANTED ON THE ORIGINAL SIX (6) SCREWS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT'S OUTCOME WAS REPORTED TO BE GOOD. CONCOMITANT DEVICES REPORTED: LOCKING CAPS (PART/LOT NUMBERS UNKNOWN, QUANTITY: 4). THIS REPORT IS FOR TWO (2) UNKNOWN CLICK-X RODS. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309399 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN LOCKING CAPS (X4)