BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF OBLIQUE (TI PEEK)OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X13 L10°

    MDR report key: 18639658 · Received February 5, 2024

    Report

    Report Number
    3005180920-2024-00038
    Event Type
    Injury
    Date Received
    February 5, 2024
    Date of Event
    January 22, 2024
    Report Date
    February 5, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    PMA / PMN Number
    K133192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24-JAN-2024: LOT 1820573: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2019. EXPIRATION DATE: 2024-05-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: ABOUT 2 MONTHS AFTER L3-L4 CIRCUMFERENTIAL FUSION SURGERY WITH POSTERIOR SCREWS AND RODS AND A MECTALIF OBLIQUE CAGE (TIPEEK 12X28X13 L10°), A REVISION SURGERY WAS PERFORMED DUE TO POSTERIOR SLIDING OF THE CAGE. NO INFORMATION IS REPORTED ABOUT THE CLINICAL STATUS OF THE PATIENT. FROM THE AVAILABLE PRE REVISION X-RAYS, WE CAN ASSESS THAT THE SCREWS REMAINED STABLE, THE CAGE SEEMS PLACED POSTERIORLY AND SLIGHTLY ROTATED (ACCORDING TO THE INDICATION REPORTED IN THE SURGICAL TECHNIQUE). THE MIGRATION OF THE CAGE SHOULD HAVE BEEN CAUSED BY A LACK OF PRIMARY STABILITY: THIS CAN BE ATTRIBUTED TO THE INITIAL POSITIONING, BUT ALSO TO OTHER POTENTIAL SURGICAL FACTORS (RELATED FOR EXAMPLE TO PREPARATION OF THE ENDPATES, POSTERIOR COMPRESSION, UNDERSIZING, ETC). THE REVISION SURGERY CONSISTED IN EXTENDING THE CONSTRUCT (ONE LEVEL ABOVE AND ONE LEVE BELOW) AND REPLACING THE OBLIQUE CAGE WITH A TRANSFORAMINAL CAGE. WE HAVE NO REASON TO SUSPECT A DEFECTIVE OR MALFUNCTIONING DEVICE.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER PRIMARY, THE OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X13 L10° WAS REVISED DUE TO POSTERIOR SLIDING AND IT HAS BEEN REPLACED BY A TRANSFORAMINAL CAGE. THE CONSTRUCT WAS STABILIZED BY ADDING SCREWS ONE LEVEL ON TOP AND BELOW. BOTH THE LEVELS ON TOP AND BELOW WERE ALREADY OSSIFIED, SO NO CAGES WERE PLACED THERE. THE SURGEON REPORTED THAT HE DOES NOT THINK THAT THE LOOSENING IS DUE TO AN IMPLANT FAILURE, BUT THAT THE CONSTRUCT WAS NOT STABLE ENOUGH AND THERE SHOULD HAVE BEEN PLACED MORE SCREWS DURING THE FIRST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621386 MECTALIF OBLIQUE (TI PEEK)OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X13 L10° SPINE FUSION DEVICE (CAGE) MAX MEDACTA INTERNATIONAL SA 1820573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention