BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABO

    MDR report key: 7222557 · Received January 26, 2018

    Report

    Report Number
    3008853203-2017-00011
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Date of Event
    December 27, 2017
    Report Date
    January 26, 2018
    Manufacturer
    NEUROSTRUCTURES, INC.
    Product Code
    KWQ
    UDI-DI
    00841508101673
    PMA / PMN Number
    K142060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS INCLUDING MATERIAL AND INSPECTION RECORDS FOR P/NS 81-0234 (LOT NO. 17083608), 81-1214 (LOT NO. 16054618), AND 81-1216 (LOT NO. 16055902 AND 16059408) WERE REVIEWED. NO RESULTING ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE PERS WERE REVIEWED FOR THE ABOVE ITEMS WITH NO IDENTIFIED PATTERN OF FAILURE MODE. A 81-0234 (UNKNOWN LOT NUMBER) REFERENCED IN (B)(4) BROKE DURING CONTOURING WITH NO PARTS RETURNED FOR INVESTIGATION. P/N 81-1214 (UNKNOWN LOT NUMBER) POTENTIAL SCREW BREAKAGE IS LISTED IN (B)(4) WITH NO DEFINITIVE ROOT CAUSE DETERMINED. NO PARTS WERE RETURNED FOR INVESTIGATION. P/N 81-1216 IS REFERENCED IN TWO OTHER PERS. (B)(4) (1 SCREW FROM LOT NO. 16059408) MALFUNCTION WAS A BREAKAGE AT THE SCREW HEAD DURING TIGHTENING. (B)(4) (4 SCREWS OF UNKNOWN LOT NUMBER) INDICATED POTENTIAL SCREW BREAKAGE WITH NO DEFINITIVE ROOT CAUSE DETERMINED. NO PARTS WERE RETURNED FOR INVESTIGATION. THE IMAGE PROVIDED CLEARLY SHOWS THE LOCKING MECHANISM MISSING ON ONE SIDE. THE MISSING MECHANISM WAS NOT PROVIDED FOR REVIEW AND CANNOT BE RETRIEVED FOR FUTURE REVIEW AND ASSESSMENT. PLATE HAS SIGNIFICANT DAMAGE BUT NO STRUCTURAL FAILURE. NO MARKS INDICATING THE NATURE OF THE SEPARATION OF THE BLOCKING MECHANISMS WERE IDENTIFIED. ALL EXISTING MECHANISMS WERE FOUND TO BE IN GOOD WORKING CONDITION. WEAR MARKS ARE PRESENT AT THE SCREW NECK AREA AND THE SCREW HEAD LARGER DIAMETER FEATURE. ONE OF THE SCREWS EXHIBITED MORE SIGNIFICANT MARKS. THOSE MARK CAN BE A RESULT OF TURNING AGAINST THE LOCKING MECHANISM OR THE PLATE. TWO OF THE SCREWS WERE BROKEN BUT NO INDICATION TO THE NATURE OF THE FAILURE. REPORT 3 OF 4.

    Description of Event or Problem · 1

    SURGEON HAD TO REVISE AN ACDF PATIENT THAT WAS JUST OVER 3 MONTHS OUT. PHYSICIAN NOTED AT 3 WEEKS THAT ONE OF THE SCREWS ON THE BOTTOM OF THE PLATE HAD BACKED OUT "ONE TURN". HE DID NOT SURGICALLY INTERVENE AT THAT TIME. THE PATIENT LATER REPORTED HEARING A POP (APPROXIMATELY 13 WEEKS POST-OP). THE PATIENT WAS SEEN BY THE SURGEON AFTER THIS EVENT. THE X-RAY REVEALED THE BOTTOM SCREW HAD BACKED OUT FURTHER, AND BOTH OF THE TOP SCREWS WERE BROKEN CLOSE TO MID-SHAFT. THE SURGEON TOOK THE PATIENT BACK TO SURGERY AND REMOVED THE PLATE AND SCREWS, EXCEPT FOR THE 2 BROKEN TIPS WHICH HE LEFT IN THE BONE. THE SURGEON CHOSE NOT TO RE-PLATE. THE PATIENT WAS PUT IN A HARD COLLAR AND WILL BE MONITORED TO SEE IF FURTHER INTERVENTION IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64769 CABO 4.0MM VARIABLE SELF TAPPING SCREW 16MM KWQ NEUROSTRUCTURES, INC. 81-1216 16059408 00841508101673

    Patients

    Seq Age Sex Outcome Treatment
    1