BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI POLYAXIAL REDUCTION HEAD FOR TI MATRIX SCREWS

    MDR report key: 4321054 · Received December 11, 2014

    Report

    Report Number
    2520274-2014-15284
    Event Type
    Malfunction
    Date Received
    December 11, 2014
    Report Date
    November 13, 2014
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER ORIGINALLY REPORTED AS 04.634.002S BUT WAS CONFIRMED PART SHOULD BE 04.634.001S. THE FOLLOWING LOTS WERE REPORTED AS THE POSSIBLE LOT NUMBER IN QUESTION: 8840709, 8895747, OR 8939691. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT L4 RIGHT SCREW HEAD IN QUESTION IS OFF THE PROPER POSITION IN A PATIENT WHO HAD L4/5TLIF OPERATION REPORTED ON (B)(6). THIS WAS FOUND BY A SURGEON'S REVIEW OF ALL THE X-RAYS OF THE PAST CASES, SINCE HE/SHE HAD ANOTHER PATIENT WHO HAD THE SAME KIND OF TROUBLE AFTER HAVING A FIXATION OPERATION REPORTED ON OCTOBER 2ND. AS FOR THE FORMER PATIENT, NO RE-OPERATION IS PLANNED SINCE THE PATIENT HAS TRANSVERSE CONNECTOR WITH NO CLINICAL SYMPTOMS AND THE BONE UNION IS ALREADY SEEN. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804543 TI POLYAXIAL REDUCTION HEAD FOR TI MATRIX SCREWS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR