BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X25 ENHANCED

    MDR report key: 8522860 · Received April 17, 2019

    Report

    Report Number
    3005180920-2019-00275
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    March 18, 2019
    Report Date
    April 17, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVD
    UDI-DI
    07630030875410
    PMA / PMN Number
    K160605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 APRIL 2019: LOT 1820615: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUL-2018. EXPIRATION DATE: 2023-07-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. AS THE SCREW IS STILL IN SITU, IT IS IMPOSSIBLE TO DEFINE WHICH LOT IS THE INVOLVED ONE, SO THE BATCH RECORD OF THE SECOND POSSIBLE LOT HAS BEEN PERFORMED AS WELL: MECTALIF ANTERIOR 03.30.132 MECTALIF ANTERIOR STAND-ALONE SCREWDIAM.5X30 ENHANCED (DOUBLE PACKAGING) LOT 1820442 (K160605): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUL-2018. EXPIRATION DATE: 2023-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. THIS PATIENT COMPLAINS FOR PAIN SHORTLY AFTER AN L5S1 FUSION THAT GAVE VERY EARLY A BROKEN SCREW IN S1. A DISC REPLACEMENT DEVICE IS VISIBLE AT L4L5 AND THE DISTAL LUMBAR LORDOSIS APPEARS TO BE VERY PRONOUNCED. WE DO NOT KNOW IF THE CAUSE OF PAIN IS DIRECTLY THE BROKEN SCREW. WE CANNOT DETERMINE WITH CERTAINTY THE CAUSE FOR SCREW FRACTURE EITHER, BUT THE COMBINATION BETWEEN VERTEBRAL ANGLES AND ADJACENT DISC REPLACEMENT DEVICE SEEMS TO BE A MECHANICALLY CHALLENGING SITUATION. THE CAUSE FOR THIS FRACTURE CANNOT BE ASCERTAINED THROUGH CLINICAL INVESTIGATION ONLY.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN WHICH WAS CAUSED BY A BROKEN MECTALIF ANTERIOR SCREW IN THE S1 VERTEBRAE AND THE CAUSE OF THE BROKEN SCREW IS UNKNOWN. THE SURGEON HAS NOT SCHEDULED A REVISION SURGERY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318434 MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X25 ENHANCED SPINE ANTERIOR STAND-ALONE SCREW OVD MEDACTA INTERNATIONAL SA 1820615 07630030875410

    Patients

    Seq Age Sex Outcome Treatment
    1 Other