BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAZZ LOCK

    MDR report key: 24342935 · Received February 16, 2026

    Report

    Report Number
    3007675554-2025-00003
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    March 13, 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 RETURNED WAS PERFORMED BY IMPLANET AND SHOWED THAT THE PEEK INSERTS WERE INSUFFICIENTLY INSERTED INTO THE BASE. THIS MAY EXPLAIN THE SURGEON'S FINDINGS DURING THE REOPERATION. A MEETING WITH THE SURGEON WAS ORGANISED IN ORDER TO REINFORCE THE SURGICAL TECHNIQUE AND HE CONTINUES USE THE JAZZ LOCK ALMOST WEEKLY IN 2025.

    Description of Event or Problem · 0

    2X JAZZ BAND AND 2X JAZZ LOCK USED IN A POSTERIOR LUMBAR FUSION, (B)(6) 2024. BANDS PASSED AROUND THE UIV+1 (L1) SPINOUS PROCESS AND TENSIONED AROUND THE ROD BILATERALLY. REOPERATION ON (B)(6) 2024. SURGEON NOTED THAT IN ONE LOCK CONNECTOR BOTH PORTIONS OF THE BAND WERE OUT OF THE LOCK CONNECTOR AND IN FOR THE SECOND LOCK CONNECTOR ONE PORTION OF THE BAND REMAINED IN THE CONNECTOR. THE REASON FOR THE RE-OPERATION WAS PATIENT WAS STILL SYMPTOMATIC, SO THE REOPERATION WAS FOR FURTHER DECOMPRESSION, AND THEY FOUND SLIPPING OF THE BAND UPON INSPECTION. DUE TO THE PATIENT'S PATHOLOGY, THE SURGEON EXTENDED THE FIXATION UP ONE LEVEL WITH PEDICLE SCREWS AND RODS. SURGICAL INDICATION : LUMBAR DECOMPRESSION AND FUSION. TYPE OF CONSTRUCT: PLIF + PEDICLE SCREWS + JAZZ LOCK. THIS REPORT IS MADE AT THAT DATE FURTHER TO THE OBSERVATIONS WRITTEN IN A FORM FDA 483 BY (B)(6), FDA INVESTIGATOR ON JULY 4, 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403943 JAZZ LOCK Bone fixation cerclage, sublaminar OWI IMPLANET NKSPNFOM-1 03607503507004

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Required Intervention