BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTLOX CERCICAL PLATE SYSTEM

    MDR report key: 2612701 · Received June 7, 2012

    Report

    Report Number
    3006082533-2012-00001
    Event Type
    Other
    Date Received
    June 7, 2012
    Date of Event
    April 22, 2012
    Report Date
    June 4, 2012
    Manufacturer
    CAPTIVA SPINE
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO INFO PROVIDED BY DISTRIBUTOR REP (B)(4), THE PT FELL AND BROKE HER ENTIRE CONSTRUCT. INCLUDED IN THE ADVERSE EVENT DATA PROVIDED WAS AN X-RAY AND A PICTURE OF THE EXPLANTED CONSTRUCT. THE IMPLANTS WERE NOT RETURNED AND COULD NOT BE EVALUATED. THE X-RAY SHOWS THAT THE PT'S CONSTRUCT HAD NOT BROKEN BUT THE VERTEBRAE HAD BROKEN DUE TO THE FALL. THE EXPLANTED CONSTRUCT PICTURE DOES NOT SHOW ANY DEVICE FAILURE OR BREAKAGE. THE REVISION PROCEDURE WAS A RESULT OF THE PT'S FALL AND ACCORDING TO THE REP THE DEVICE DID NOT CONTRIBUTE TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, AN (B)(6) FEMALE AFTER 2 LEVEL ACDF FELL AND BROKE OUT HER ENTIRE CONSTRUCT. DR (B)(6) HAD DIFFICULTY REMOVING THE SCREWS (ULTIMATELY HE COULD NOT) WITH THE REMOVAL TOOL. THE REMOVAL TOOL DID NOT DISPLACE THE NITINOL ANTI-BACK OUT WIRE ENOUGH (RAIL LOCK) FOR THE SCREWS TO COME OUT. AS SUCH, HE ENDED UP OF THE CONSTRUCT WAS FACILITATED BY THE FACT THAT THE CONSTRUCT WAS LOOSE FOLLOWING THE FRACTURE. (B)(6) INDICATED THAT A SMARTLOX 42MM 2 LEVEL PLATE AND 16MM SCREWS QTY 4 AND 14MM SCREWS QTY 2 WERE THE ORIGINAL DEVICES USED IN THE CONSTRUCT, WHICH WERE REMOVED FROM THE PT. THE SURGEON REPLACED THE REMOVED CONSTRUCT WITH A SMARTLOX 38MM PLATE WITH 12MM 4.5 RESCUE SCREWS IN FRONT. SYNTHES POSTERIOR LATERAL MASS SCREWS/RODS IN BACK. C5-7 ON BOTH SIDES. DEVICES WERE NOT RETURNED NOR WAS THE DATE OF THE ORIGINAL IMPLANTATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTLOX CERCICAL PLATE SYSTEM SPINAL INTERVENTION BODY FIXATION ORTH KWQ CAPTIVA SPINE CP30042 05110013

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention