BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5MM X 40MM S-LOK POLYAXIAL

    MDR report key: 4180561 · Received October 15, 2014

    Report

    Report Number
    3005739886-2014-00045
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 19, 2014
    Manufacturer
    PRECISION SPINE, INC
    Product Code
    MNH
    PMA / PMN Number
    K071438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS AVAILABLE FOR EVALUATION. WITHOUT LOT IDENTITY, REVIEW OF MANUFACTURING HISTORY AND LOT SPECIFIC COMPLAINT HISTORY ARE NOT POSSIBLE. REVIEW OF COMPLAINT HISTORY, FROM JANUARY 01, 2012 THROUGH SEPTEMBER 26, 2014, FOR THE SLPXXX FAMILY OF S-LOK PLYAXIAL SCREWS DID NOT IDENTIFY A TREND FOR REPORTS OF FRACTURE. ALTHOUGH THE EXACT ROOT CAUSE OF THE ALLEGED FRACTURE COULD NOT BE DETERMINED, INFORMATION PROVIDED INDICATES THAT THE PATIENT MAY NOT HAVE FOLLOWED POSTOPERATIVE INSTRUCTION REGARDING PHYSICAL ACTIVITY AND LOAD BEARING. FRACTURE OF DEVICE IS A KNOWN RISK OF THIS PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2014 UTILIZING THE S-LOK PEDICLE SCREW SYSTEM. SUBSEQUENTLY, INFORMATION INDICATES THAT A SLP6540 6.5MM X 40MM S-LOK POLYAXIAL SCREW FRACTURED. NO REVISION HAS BEEN REPORTED. IT WAS NOTED THAT THE PATIENT WAS LIFTING A MOTOR AND WORKED THREE JOBS, ONE OF WHICH REQUIRED LIFTING OF LUGGAGE BAGS. THE IMPLANTING SURGEON INDICATED THAT THE SCREW FRACTURE WAS THE RESULT OF MICRO-MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654571 6.5MM X 40MM S-LOK POLYAXIAL MNI MNH PRECISION SPINE, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1