BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTERPIECE? PLATE FIXATION SYSTEM

    MDR report key: 3756002 · Received April 17, 2014

    Report

    Report Number
    1030489-2014-02208
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NQW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOCATION : HOSPITAL. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG #S 853-012, 853-467, AND 853-471 AND 510K # K050082 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH CERVICAL SPONDYLOTIC MYELOPATHY UNDERWENT A CERVICAL LAMINOPLASTY AT C4. AFTER DETERMINING THE PLATE SIZE WITH TRIALS AND THE APPROPRIATE PLATE WAS POSITIONED, THE PHYSICIAN UNINTENTIONALLY EXERTED TOO MUCH FORCE ON THE LAMINA CAUSING IT TO BECOME "A BIT UNSTABLE". THEREAFTER, IT WAS REPORTED THAT "TWO SCREWS WERE INSERTED INTO LATERAL MASS AND ANOTHER ONE WAS TRIED TO BE INSERTED INTO LAMINA. THEN, IT WAS FOUND THAT THE PLATE¿S MOUTH DID NOT CATCH LAMINA PROPERLY AND THE PLATE WAS VERY SHAKY." ACCORDING TO THE REPORT, AN 11MM SCREW WA INSERTED ON THE ANGLE, BUT SCREW INSERTION WAS ULTIMATELY UNSUCCESSFUL BECAUSE OF THE UNSTABLE LAMINA. THUS, ALL THE IMPLANTS INCLUDING THE PLATE AND SCREWS WERE REMOVED. THE LAMINA WAS ALSO REMOVED AND THE OPERATION WAS COMPLETED. THE SUBSEQUENT PROCEDURE CHANGE WAS REPORTEDLY CLOSE TO LAMINECTOMY. THE SURGICAL TIME WAS EXTENDED 16-30 MINUTES DUE TO THE INCIDENT. REPORTEDLY, THE SURGERY WAS INTENDED TO PERFORM DECOMPRESSION AND THAT WAS EVENTUALLY ACHIEVED. THE PATIENT¿S POSTOPERATIVE CLINICAL COURSE WAS REPORTEDLY WELL AND PREOPERATIVE SYMPTOMS IMPROVED. NO REVISION SURGERY WAS SCHEDULED. ACCORDING TO THE REPORT, THERE WAS NO INTRAOPERATIVE MALFUNCTION OF IMPLANTS AND INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234673 CENTERPIECE? PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDICS NA 0269833W

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention 2.6X5MM SCREWS (X2), 2.6X11MM SCREW (1)