BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAZZ LOCK

    MDR report key: 24342933 · Received February 16, 2026

    Report

    Report Number
    3007675554-2025-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    February 12, 2024
    Report Date
    November 13, 2025
    Manufacturer
    IMPLANET
    Product Code
    OWI
    UDI-DI
    03607503507004
    PMA / PMN Number
    K153348
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EXPERTISE OF JAZZ LOCK IMPLANTS RETURNED BY DR ALFORD SEEMS TO INDICATE THAT THIS "LOOSENING" OF THE BRAIDS IS NOT THE CONSEQUENCE OF A LOCKING ANOMALY OF THE JAZZ LOCK IMPLANTS. THE MOST LIKELY HYPOTHESIS TO EXPLAIN THE LOOSENING OF THE ASSEMBLY WOULD BE INSUFFICIENT TENSION APPLIED DURING THE INITIAL SURGERY ON (B)(6) 2024. HOWEVER, THE ELEMENTS IN OUR POSSESSION DO NOT ALLOW TO DETERMINE WITH CERTAINTY THE ORIGIN OF THIS EVENT.

    Description of Event or Problem · 0

    TWO JAZZ BAND IMPLANTS (LOT # 210954 AND LOT # 220386) AND TWO JAZZ LOCK IMPLANTS (LOT # LXJA-LXJI AND LOT # MQXZ-LXJM) WERE IMPLANTED IN A 58-YEAR-OLD PATIENT ON (B)(6) 2024 AT (B)(6) HOSPITAL DURING A POSTERIOR LUMBAR FUSION SURGERY. REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO INFECTION AND THE SURGEON NOTED THAT THE BANDS WERE "LOOSE". THIS REPORT IS MADE AT THAT DATE FURTHER TO THE OBSERVATIONS WRITTEN IN A FORM FDA 483 BY MR (B)(4), FDA INVESTIGATOR ON JULY 4, 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403825 JAZZ LOCK Bone fixation cerclage, sublaminar OWI IMPLANET LXJA-LXJI 03607503507004

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Required Intervention