BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINE SCREW

    MDR report key: 2943347 · Received February 5, 2013

    Report

    Report Number
    2520274-2013-00769
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 10, 2013
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DIMENSIONS COULD NOT BE MEASURED AS ONLY THE SMALL METAL PIECE WAS RETURNED. UNFORTUNATELY WE ARE NOT ABLE TO COMPREHEND THIS REPORTED PROBLEM. WE CAN ONLY ASSUME THAT THIS SMALL METAL SHARD GOT SHEARED OFF DURING THE SCREW INSERTION. IT IS POSSIBLE THE SCREW WAS NOT SUFFICIENTLY POSITIONED. ON AN ANGLE, AND A PART OF THE THREAD CAME OFF.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) PROVIDES INFORMATION FROM A FACILITY IN (B)(6). IT WAS REPORTED THAT THE PHYSICIAN FOUND AN UNIDENTIFIED METAL PIECE DURING AN OPERATIVE PROCEDURE. AFTER THE SCREW INSERTION (USING MATRIX PEDICLE POLYAXIAL SCREWS) TO L4-S, THE DOCTOR FOUND THE METAL PIECE. NO ADVERSE EFFECT TO THE PATIENT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47970 SPINE SCREW SPINE SCREW HWC

    Patients

    Seq Age Sex Outcome Treatment
    1