BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF OBLIQUE TIPEEK 10X28X15 L10°

    MDR report key: 18894638 · Received March 13, 2024

    Report

    Report Number
    3005180920-2024-00106
    Event Type
    Injury
    Date Received
    March 13, 2024
    Date of Event
    February 14, 2024
    Report Date
    May 3, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630971291089
    PMA / PMN Number
    K212831
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D MANAGER: THE CAGE REF NO. (B)(4) , LOT NO. 2122267, HAS VARIOUS SCRATCHES ON THE ANTERIOR SIDE OF THE IMPLANT. THE SCRATCHES ARE COMPATIBLE WITH THE ADDITIONAL INFORMATION RECEIVED AND THEY ARE RELATED TO THE REMOVAL OF THE IMPLANT DURING THE ALIF REVISION SURGERY. THE CRANIAL AND CAUDAL TEETH AND THE REST OF THE IMPLANT BODY, INSTEAD, DO NOT APPEAR DAMAGED. THE ROOT CAUSE OF THE COMPLAINT (BACKING OUT OF THE CAGE) COULD BE RELATED TO THE IMPERFECT COMPRESSION APPLIED ON THE IMPLANT.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13-MAR-2024. LOT 2122267: (B)(4) MANUFACTURED AND RELEASED ON 18-OCT-2021. EXPIRATION DATE: 2026-09-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ONE ITEM OF THIS LOT HAS BEEN SOLD. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: ABOUT 4 MONTHS AFTER UNDERGOING DOUBLE-LEVEL CIRCUMFERENTIAL FUSION SURGERY WITH POSTERIOR SCREWS, RODS, AND 2 CAGES, A REVISION SURGERY WAS REQUIRED DUE TO THE LOWER CAGE BACKING OUT (MECTALIF OBLIQUE TIPEEK 10X28X15 L10°). THE PATIENT REPORTED DISCOMFORT AND UNDERWENT A FOLLOW-UP X-RAY THAT DOCUMENTED THE CAGE MOBILIZATION. UPON REVIEWING THE AVAILABLE PRE-REVISION X-RAYS, IT WAS EVIDENT THAT THE LOWER CAGE HAD SHIFTED POSTERIORLY. SUCH MIGRATION WITHIN A SHORT TIMEFRAME LIKELY STEMMED FROM INADEQUATE PRIMARY STABILITY THAT CAN BE ATTRIBUTED TO SEVERAL POSSIBLE FACTORS: INITIAL POSITIONING ISSUES, ENDPLATE PREPARATION, UNDERSIZING OR ALSO THE BIOLOGICAL CHARACTERISTICS OF THE HOST BONE. THE REVISION SURGERY CONSISTED IN REPLACING THE DISPLACED CAGE, THE PREVIOUS SCREWS AND RODS, AND IT COMPLETED SUCCESSFULLY. WE HAVE NO EVIDENCE TO DEFINITELY SUSPECT A DEFECTIVE OR MALFUNCTIONING DEVICE.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 4 MONTHS AFTER THE PRIMARY DUE TO ONE OF THE CAGES BACKED OUT. THE SURGEON REPLACED THE INTERBODY CAGE ANTERIORLY WITH A COMPETITOR ALIF CAGE AND THEN NEW SCREWS (8X50) WERE USED WITH A POSTERIOR APPROACH TO REPLACE THE OLD ONES (7X50) THAT WERE IMPLANTED DURING THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 4 MONTHS AFTER THE PRIMARY DUE TO ONE OF THE CAGES BACKED OUT. THE SURGEON REPLACED THE INTERBODY CAGE AND NEW SCREWS WERE USED TO REPLACE THE OLD ONES THAT WERE IMPLANTED DURING THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211792 MECTALIF OBLIQUE TIPEEK 10X28X15 L10° SPINE CAGE MAX MEDACTA INTERNATIONAL SA 2122267 07630971291089

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention