BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW 7X45

    MDR report key: 7412276 · Received April 10, 2018

    Report

    Report Number
    3005180920-2018-00218
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    March 14, 2018
    Report Date
    April 10, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030834295
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 APRIL 2018. PEDICLE SCREW 7X45 REFERENCE 03.50.031 (K121115). (B)(4). PEDICLE SCREW 7X45 REFERENCE 03.50.031 (K121115). (B)(4). PEDICLE SCREW 7X50 REFERENCE 03.50.032 (K121115). (B)(4). PEDICLE SCREW 7X50 03.50.032 (K121115). (B)(4). BENT ROD TI 5.5X45 MM REFERENCE 03.50.452 (K121115). (B)(4).

    Description of Event or Problem · 1

    REVISION SURGERY 1 YEAR AND 1 MONTH AFTER PRIMARY SURGERY (LEVELS WERE L3-4) DUE TO PAIN, THE VERTEBRAE DIDN'T FUSE, THE SURGEON REVISED L3-4. THE SCREWS AND RODS (NOT LOOSE) WERE REMOVED AND REPLACED. THE INTERBODY REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259125 PEDICLE SCREW 7X45 PEDICLE SCREW 7X45 KWP MEDACTA INTERNATIONAL SA 161873 07630030834295

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention