BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING)

    MDR report key: 8953728 · Received September 2, 2019

    Report

    Report Number
    3005180920-2019-00746
    Event Type
    Malfunction
    Date Received
    September 2, 2019
    Date of Event
    August 8, 2019
    Report Date
    September 2, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVD
    UDI-DI
    07630030875434
    PMA / PMN Number
    K160605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 AUGUST 2019: LOT 1820905: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-NOV-2018. EXPIRATION DATE: 2023-11-06. 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: SCREW FRACTURE IN AN ALIF LUMBAR STABILIZATION FEW MONTHS AFTER SURGERY. DUE TO AN OSTEOPHYTE, THE OPTIMAL POSITION OF THE CAGE COULD NOT BE REACHED AND THEREFORE THE MECHANICS OF THE COMPOUND RESULTED AFFECTED. THE MOST PROBABLE CAUSE FOR THE FRACTURE IS THE SUBOPTIMAL POSITION OF THE CAGE. WE CANNOT DETERMINE FROM THE INFORMATION RECEIVED IF THE BROKEN SCREW IS THE CAUSE OF PAIN: THAT IS POSSIBLE, BUT IT'S ALSO POSSIBLE THAT THE FAILED (OR DELAYED) FUSION IS THE MAIN CAUSE. NO REASON TO SUSPECT A FAULTY DEVICE. ADDITIONAL IMPLANT INVOLVED: MECTALIF ANTERIOR 03.30.133 MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING) (K160605) LOT. 1820443. BATCH REVIEW PERFORMED ON 16 AUGUST 2019: LOT 1820443: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2018. EXPIRATION DATE: 2023-05-14. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A SCREW FRACTURE. DURING THE PRIMARY SPINE SURGERY, A LARGE ANTERIOR OSTEOPHYTE WAS PRESENT AND IMPEDED THE CAGE TO BE PLACED ALL THE WAY POSTERIOR TOWARDS THE BACK OF THE VERTEBRAL BODY. THE IMPLANT WAS PROUD ANTERIORLY AND NOT IN AN IDEAL POSITION. THE PATIENT WAS ALSO FRACTURED IN THE ANTERIOR SUPERIOR CORNER OF S1. THE PATIENT DID NOT SUSTAIN ANY ADDITIONAL SUBSIDENCE OR INSTABILITY. THE SURGEON DOES NOT PLAN ON REVISING THE PATIENT AT THIS TIME, BUT WILL MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747857 MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING) CERVICAL ANTERIOR BONE SCREW OVD MEDACTA INTERNATIONAL SA 1820905 07630030875434

    Patients

    Seq Age Sex Outcome Treatment
    1 Other