BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTERPIECE? PLATE FIXATION SYSTEM

    MDR report key: 4699868 · Received April 16, 2015

    Report

    Report Number
    1030489-2015-00805
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Report Date
    March 19, 2015
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    NQW
    PMA / PMN Number
    SEE H10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). PMA 510(K): THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG # 853-465 AND 510K # K050082 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE PATIENT UNDERWENT A LAMINOPLASTY SURGERY AT LEVELS C3 TO C6. POST-OP, IT WAS REPORTED THAT A SCREW HAD BACKED OUT AT THE C6 LAMINA. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255778 CENTERPIECE? PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDIC, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE FIXATION SYSTEM