BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER CERVICAL PLATING (SCP) SYSTEM

    MDR report key: 4210938 · Received October 29, 2014

    Report

    Report Number
    3005031160-2014-00013
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    January 27, 2014
    Report Date
    October 29, 2014
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K052292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 10/29/2014. ADD'L MODEL(S) # N60000146, N60000117. ADD'L LOT(S) # 80900, 77558.

    Description of Event or Problem · 1

    ON OR ABOUT (B)(6) 2009, [MRS] HAD CERVICAL SPINE SURGERY AT (B)(6) WHEREIN SCREWS WERE IMPLANTED. IN (B)(6), 2014, IT WAS DISCOVERED THAT A SCREW(S) HAD BROKEN. ON (B)(6) 2014, A SECOND SURGERY WAS PERFORMED AT (B)(6) WHERE THE SUBJECT SCREW(S) WERE REMOVED AND NEW SCREWS PLACED.

    Description of Event or Problem · 1

    ON 11/16/2015, X-SPINE RECEIVED THE FOLLOWING FOR EVAL; ONE BROKEN 4 X 14 MM FIXED SPIDER SCREW (PART # N60000146, LOT # 80900) AND SIX INTACT 4 X 14 MM VARIABLE SPIDER SCREWS (PART #N60000136, LOT #80627), AND ONE 62 MM THREE LEVEL SPIDER PLATE (PART #N60000117, LOT #77558). THESE PARTS WERE EXPLANTED ON OR ABOUT (B)(6) 2014 AND ARE BEING INVESTIGATED IN REFERENCE TO AMENDMENT OF THE ORIGINAL MDR FILED 10/29/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693518 SPIDER CERVICAL PLATING (SCP) SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ X-SPINE SYSTEMS, INC. N60000136 80627

    Patients

    Seq Age Sex Outcome Treatment
    1 Other