BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD

    MDR report key: 16002393 · Received December 19, 2022

    Report

    Report Number
    3005180920-2022-00932
    Event Type
    Injury
    Date Received
    December 19, 2022
    Date of Event
    June 20, 2022
    Report Date
    December 19, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVD
    PMA / PMN Number
    K183426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 NOV 2022. LOT 2023945: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2021. EXPIRATION DATE: 2026-01-28. 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. OTHER COMPONENT POTENTIALLY INVOLVED: MECTALIF ANTERIOR 03.30.146 MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD (K183426) LOT. 2124222: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2021. EXPIRATION DATE: 2026-08-22. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: AT 1 YEAR AFTER LUMBO-SACRAL STABILIZATION, FUSION DID NOT TAKE PLACE AND ONE OR POSSIBLY TWO SACRAL SCREWS OF THE STANDALONE CAGE BROKE. THIS PATIENT HAD LATERAL PARS DEFECTS AND SPONDYLOLISTHESIS, SITUATIONS THAT MAY SUBJECT THE IMPLANT TO INCREASED STRESS; IN THESE CONDITIONS, IF FUSION DOES NOT TAKE PLACE, THE IMPLANT IS SUBJECT TO PROLONGED INTENSE STRESS AND THEREFORE FRACTURE MAY OCCUR AFTER THE STANDARD FUSION TIME (BETWEEN 6 AND 12 MONTHS, NORMALLY). PRELIMINARY INVESTIGATION PERFORMED BY R&S SPINE DIRECTOR: THE INSTABILITY CAUSED BY THE PARS DEFECT DID HIGHLY LIKELY CONTRIBUTE TO THE FRACTURE OF THE SCREWS. ITS RECOMMENDED IN THE LITERATURE TO BACK UP THESE TYPE OF CASES WITH POSTERIOR INSTRUMENTATION.

    Description of Event or Problem · 0

    THE SURGEON NOTED AFTER SURGERY THAT THE S1 SCREW/S HAD BROKEN. HE NOTED THERE WAS NOT A COMPLETE FUSION ACROSS THE CAGE AND EVENTUALLY DECIDED TO FURTHER STABILIZE THE PATIENT WITH POSTERIOR FIXATION 6 MONTHS AFTER THE PRIMARY SURGERY. THIS PATIENT HAD BILATERAL PARS DEFECT ALREADY AT THE DAY OF THE PRIMARY SURGERY WITH EVEN A GRADE 1 OF SPONDYLOLISTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152533 MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD ANTERIOR STAND-ALONE SCREW OVD MEDACTA INTERNATIONAL SA 03.30.146 2023945

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Required Intervention