BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MIRS POLYAXIAL SCREW BODY

    MDR report key: 6770792 · Received August 7, 2017

    Report

    Report Number
    1000562954-2017-10161
    Event Type
    Injury
    Date Received
    August 7, 2017
    Report Date
    July 10, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    NKB
    PMA / PMN Number
    K113044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. THIS PART DATA WAS CREATED IN ERROR. ONLY THE LOCKING CAPS WERE LOOSENED. 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

    (B)(6). DATE OF DEVICE LOOSENING IS NOT KNOWN. ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, KWP. LOT NUMBERS PROVIDED FOR PART 04.631.500 ARE 7951942 X2, 7918298 X2, 7918302 X5, AND 7964212 X1. IT IS NOT KNOWN WHICH LOT NUMBER IS ASSOCIATED WITH THIS SCREW BODY. (B)(4) LOT NUMBER UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT WAS IMPLANTED WITH TWO (2) RODS, UNKNOWN NUMBER OF MINIMALLY INVASIVE REDUCTION SCREWS (MIRS) AND UNKNOWN NUMBER OF MIRS LOCKING CAPS AT UNKNOWN LEVELS ON (B)(6) 2012. ON UNKNOWN DATE X-RAYS REVEALED THAT SOME OF THE LOCKING CAPS HAD LOOSENED. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 FOR REVISION SURGERY. IT IS NOT KNOWN IF ANY ADDITIONAL HARDWARE WAS IMPLANTED AT THAT TIME OR IF ALL HARDWARE WAS SIMPLY REMOVED. CONCOMITANT DEVICES REPORTED: ROD (QUANTITY 2); SCREW. THIS REPORT IS FOR ONE (1) MIRS POLYAXIAL SCREW BODY. THIS IS REPORT 4 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552323 TI MIRS POLYAXIAL SCREW BODY ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES MEZZOVICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROD (PART AND LOT UNKNOWN, QTY 2)| SCREW (PART AND LOT UNKNOWN, QTY UNKNOWN)