BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KEYLIFT XL 20MM LG X 12-16MM

    MDR report key: 25000471 · Received April 27, 2026

    Report

    Report Number
    MW5187298
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 21, 2026
    Manufacturer
    FLOSPINE LLC.
    Product Code
    PEK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PATIENT WITH A KEYLIFT XL 20 MM LG X 12-16 MM EXP IMPLANT CAME IN APPROXIMATELY 6 WEEKS POST-OP COMPLAINING OF AN OPEN INCISION AFTER BENDING FORWARD. THE PATIENT REPORTED MILD PAIN (B)(6) AND WAS DOCUMENTED TO BE DOING WELL WITH NO SIGNIFICANT DISCOMFORT. THE PATIENT WAS TREATED AND THE INCISION WAS CLOSED. MEDICAL HISTORY OF THE PATIENT INCLUDES BODY MASS INDEX (BMI) OF 33, NON-SMOKER, AND TYPE 2 DIABETES. DURING THIS FOLLOW UP ON (B)(6) 2026 WITH THE PATIENT, NEW IMAGES OF THE IMPLANT WERE OBTAINED. THE NEW IMAGE SHOWS THAT THE EXPANSION MECHANISM OF THE KEYLIFT XL 20 MM LG X 12-16 MM EXP IMPLANT WAS NOT FULLY DEPLOYED AND LOCKED. THE SCREW WAS OBSERVED AS BEING STILL THREADED INTO THE EXPANDING WEDGE, BUT THE WEDGE WAS NOT ENGAGED IN THE DISTAL LOCKING GROOVES OF THE IMPLANT. THE HEAD OF THE EXPANSION SCREW WAS OBSERVED TO BE PROTRUDING FROM THE POSTERIOR SURFACE OF THE IMPLANT AND THE RETAINING RING WAS NOT VISIBLE ON THE PROVIDED IMAGES. IMAGES SHOWED THAT THE SUPERIOR ARM OF THE IMPLANT WAS DEFORMED IN THE INFERIOR DIRECTION, INDICATING THAT THE IMPLANT HAD BEEN SUBJECTED TO LOADING WITHOUT THE EXPANSION MECHANISM BEING LOCKED IN PLACE. IT WAS DISCOVERED BY THE PHYSICIAN THAT THE PATIENT WAS NOT COMPLIANT WITH POST-OPERATIVE INSTRUCTION AND ACTIVITY LIMITATIONS AND WAS NOT BRACED UNTIL ONE MONTH AFTER SURGERY WHEN THE PATIENT WAS EVENTUALLY PROVIDED WITH AN LSO BRACE. IN A SUBSEQUENT PROCEDURE ON (B)(6) 2026, THE DAMAGED IMPLANT WAS REMOVED WITH LITTLE COLLATERAL DAMAGE TO THE SPINAL ANATOMY AND REPLACED WITH A NEW KEYLIFT XS [10-14 XS] IMPLANT. THE XS 10-14 IMPLANT WAS DETERMINED TO BE A MORE APPROPRIATE SIZE FOR THE PATIENT'S ANATOMY. THE SCREW WAS OBSERVED AS BEING STILL THREADED INTO THE EXPANDING WEDGE, BUT THE WEDGE WAS NOT ENGAGED IN THE DISTAL LOCKING GROOVES OF THE IMPLANT. THE HEAD OF THE EXPANSION SCREW WAS OBSERVED TO BE PROTRUDING FROM THE POSTERIOR SURFACE OF THE IMPLANT AND THE RETAINING RING WAS NOT VISIBLE ON THE PROVIDED IMAGES. IMAGES SHOWED THAT THE SUPERIOR ARM OF THE IMPLANT WAS DEFORMED IN THE INFERIOR DIRECTION, INDICATING THAT THE IMPLANT HAD BEEN SUBJECTED TO LOADING WITHOUT THE EXPANSION MECHANISM BEING LOCKED IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93773 KEYLIFT XL 20MM LG X 12-16MM SPINOUS PROCESS PLATE PEK FLOSPINE LLC. KEYLIFT XL 1793

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention