BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW 03.52.314 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM

    MDR report key: 16741313 · Received April 14, 2023

    Report

    Report Number
    3005180920-2023-00272
    Event Type
    Injury
    Date Received
    April 14, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 14, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030857461
    PMA / PMN Number
    K141988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 MARCH 2023: LOT 2125448: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2021. EXPIRATION DATE: 2026-OCT-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: A FEW DAYS AFTER PRIMARY LUMBAR POSTERIOR STABILIZATION SURGERY, THE SURGEON FINDS THAT TWO PEDICLE SCREWS ARE IN FACT OUTSIDE OF THE VERTEBRAL BODY. WE DO NOT KNOW IF THIS SITUATION WAS ALREADY PRESENT RIGHT AFTER SURGERY OR IF IT WAS AN EVOLUTIONARY STATUS. IN THE FORMER CASE, WE HAVE NO INFORMATION AS TO WHY NO ACTION WAS TAKEN DURING PRIMARY SURGERY. IN THE LATTER CASE, WE HAVE NO VIABLE HYPOTHESIS TO OFFER AS TO THE MECHANICS OF SUCH UNFAVORABLE EVOLUTION. WE CAN HARDLY IMAGINE THAT THIS IS DUE TO A DEFECTIVE DEVICE. MYSOLUTION PLANNING REVIEW: OUR ANALYSIS OF THE MYSPINE PROCESS IN THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. WE REPRINTED THE GUIDES L02 AND L03 AND CONFIRMED THAT THE FITTING IS STABLE AND UNIVOCAL. OTHER DEVICE INVOLVED: PEDICLE SCREW 03.52.314 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM (K141988) LOT 2125448: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2021. EXPIRATION DATE: 2026-OCT-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    ABOUT 12 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE RIGHT L2 AND L3 SCREWS WERE OUTSIDE THE VERTEBRAL BODY. THE SCREWS WERE PROBABLY MISPLACED DURING THE PRIMARY SURGERY; ALTHOUGH THE POSITION WAS CHECKED DURING SURGERY WITH FLUOROSCOPY. THE SURGEON REVISED THE 2 MISPLACED SCREWS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT WITH SCOLIOSIS. NO ISSUE WITH THE MYSPINE GUIDES OCCURRED DURING THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305264 PEDICLE SCREW 03.52.314 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM SPINE PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 03.52.314 2125448 07630030857461

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention