BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW LATERAL CONNECTOR L150

    MDR report key: 18317804 · Received December 13, 2023

    Report

    Report Number
    3005180920-2023-00977
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    November 15, 2023
    Report Date
    December 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630345703231
    PMA / PMN Number
    K203482
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20-NOV-2023. LOT 2023628: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2021. EXPIRATION DATE: 2026-06-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 07 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: A L2-ILIUM FUSION WAS PERFORMED AS REVISION SURGERY USING MUST SCREW SYSTEM AND TLIF CAGE (LIKELY AT L5-S1 LEVEL). AFTER LESS THAN 6 MONTHS (DATE UNSPECIFIED), THE PATIENT COMPLAINED OF BACK PAIN AND UNDERWENT X-RAY, SHOWING ON THE RIGHT SIDE THE BREAKAGE OF THE ROD AT LUMBO-SACRAL JUNCTION AND S1 SCREW. ON THE LEFT SIDE A LONG LATERAL CONNECTOR (150 MM, REF. 03.50.106) WAS USED AS LONGITUDINAL ROD FROM L2 TO THE SACRUM AND ENGAGED WITH A SHORT HORIZONTAL ROD, UP TO THE LEFT ILIAC SCREW. THIS UNUSUAL CONSTRUCT BROKE AS WELL BEFORE FUSION OCCURRED. MOREOVER, THE PATIENT IS REPORTED TO BE OVERWEIGHT (97 KG), HEAVY SMOKER AND WITH MULTIPLE COMORBIDITIES. ALL THESE ARE DESCRIBED IN THE LITERATURE AS RISK FACTORS FOR FUSION FAILURE. SO, THE BREAKEAGE COULD HAVE BEEN CAUSED BY CUMULATION OF SEVERAL RISK FACTORS: THE OVERLOAD OF THE SYSTEM AT THE LUMBO-SACRAL JUNCTION, LATERAL CONNECTOR USED LONGITUDINALLY, LACK OF OSSEOUS FUSION (DUE TO PATIENTS CHARACTERISTICS), REDUCED LUMBO-SACRAL LORDOSIS. WITH THE INFORMATION AT HAND, IT WOULD BE DIFFICULT TO SUSPECT A DEFECTIVE OR MALFUNCTIONING DEVICE. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 20-NOV-2023. PEDICLE SCREW 03.50.016 PEDICLE SCREW 6X35 (K121115) LOT 2123375: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUL-2021. EXPIRATION DATE: 2026-07-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.50.801 ANODIZED ROD TI 5.5X200 (K162061) LOT 1922359: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-AUG-2019. EXPIRATION DATE: 2024-07-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO PAIN, THE LATERAL CROSS-CONNECTOR, THE RIGHT ROD AND A PEDICLE SCREW WERE BROKEN, 5 MONTHS AFTER THE PREVIOUS REVISION SURGERY (T-LIF SURGERY, THE PATIENT HAD EXPEDIUM SYSTEM FROM DEPUY SYNTHES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779405 PEDICLE SCREW LATERAL CONNECTOR L150 LATERAL CONNECTOR NKB MEDACTA INTERNATIONAL SA 2023628 07630345703231

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention