BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENZA ZERO-PROFILE ANTERIOR INTERBODY FUSION

    MDR report key: 7472669 · Received April 30, 2018

    Report

    Report Number
    3010197239-2018-00007
    Event Type
    Malfunction
    Date Received
    April 30, 2018
    Date of Event
    April 5, 2018
    Report Date
    April 27, 2018
    Manufacturer
    CAMBER SPINE TECHNOLOGIES
    Product Code
    OVD
    PMA / PMN Number
    K153720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON REPORTED THAT THE PATIENT HAD UNDERGONE A LEVEL 3 ALIF (L3-S1) SURGERY ON (B)(6) 2018 WITH NO COMPLICATIONS. THE PATIENT HAD A 2ND SURGERY ON (B)(6) 2018 TO PLACE PEDICLE SCREWS AT L4-L5 AS PLANNED. BOTH SURGERIES WERE PERFORMED AS INTENDED WITH NO REPORTED COMPLICATIONS. IT WAS REPORTED BY A CAMBER SALES REP THAT DURING A ROUTINE 6-WEEK POST-OP APPOINTMENT ON (B)(6) 2018, PATIENT X-RAYS OF THE OPERATIVE LEVELS INDICATED THAT THE IMPLANT AT L3-L4 HAD MIGRATED FROM THE ORIGINAL IMPLANT SITE. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. DURING THIS PROCEDURE, THE SURGEON CONFIRMED THE MIGRATION OF THE L3-L4 IMPLANT AND EXTRACTED THE DEVICE. THIS DEVICE WAS REPLACED WITH ANOTHER IMPLANT. IN ADDITION, THE SURGEON VERIFIED THE PLACEMENT OF THE ORIGINAL L4-L5 AND L5-S1 IMPLANTS FROM THE ORIGINAL LEVEL 2 ALIF AND REPORTED THAT IMPLANTS WERE LOCATED IN THE CORRECT POSITIONS (I.E., NO OTHER MIGRATION). THE SURGEON REPORTED THAT THE SURGERY WAS PERFORMED AS INTENDED WITH NO COMPLICATION. AS A FOLLOW-UP, THE SURGEON PROVIDED A STATEMENT DOCUMENTING THAT HE INSPECTED THE IMPLANT AND BELIEVES THAT THERE ARE NO STRUCTURAL DEFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CAMBER SALES REP THAT DURING A ROUTINE 6-WEEK POST-OP APPOINTMENT ON (B)(6) 2018, A PATIENT'S X-RAYS INDICATED THAT THE CAMBER ENZA IMPLANT ((B)(6); L/N JP02017K) HAD MIGRATED FROM THE ORIGINAL POSITION IN THE L3-L4 DISC SPACE. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018, AND THE SURGEON EXTRACTED THE DEVICE. THIS IMPLANT WAS REPLACED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314326 ENZA ZERO-PROFILE ANTERIOR INTERBODY FUSION INTERVERTEBRAL BODY FUSION DEVICE OVD CAMBER SPINE TECHNOLOGIES JP02017K

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention