BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8955164 · Received September 3, 2019

    Report

    Report Number
    3005180920-2019-00745
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 8, 2019
    Report Date
    September 3, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVD
    UDI-DI
    07630030875434
    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 13 AUGUST 2019 LOT 1620158: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUL-2016. EXPIRATION DATE: 2021-07-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 2 OTHER SIMILAR REPORTED EVENT. SCREW BREAKAGE OCCURRED 3 MONTHS AFTER IMPLANTATION. IN SPINAL FUSION, SURGERY INSTRUMENTATION IS USED AS A TEMPORARY STABILIZER UNTIL OSSEOUS FUSION IS COMPLETE. WITHOUT OSSEOUS FUSION IMPLANTS ARE PRONE TO EVENTUAL FAILURE UNDER PHYSIOLOGICAL MECHANICAL STRESS. IN THIS CASE THE REASON OF FUSION FAILURE IS NOT KNOWN: NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS AND COMORBIDITIES THAT COULD HAVE PREVENTED BONE FORMATION IS AVAILABLE. OUR OPINION, BASED ON THE AVAILABLE INFORMATION, IS THAT FAILED FUSION IS THE MOST LIKELY CAUSE FOR THIS FRACTURE. ONLY 1 SCREW IS BROKEN BUT IT IS UNKNOWN WHICH ONE IT IS. SO HERE BELOW DETAILS OF OTHER REF. AND LOT NUMBER OF SCREW USED. BATCH REVIEW PERFORMED ON 13 AUGUST 2019: MECTALIF ANTERIOR 03.30.133 MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING) LOT. 1820443 (K160605): (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 FOR A POST-OP X-RAY 2 MONTHS AND 10 DAYS AFTER PRIMARY AND IT WAS OBSERVED THAT AN ALIF SCREW HAD FRACTURED. THE REASON FOR THE SCREW FRACTURE IS UNKNOWN. 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
    749285 MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING) SPINE STAND-ALONE SCREW OVD MEDACTA INTERNATIONAL SA 1620158 07630030875434

    Patients

    Seq Age Sex Outcome Treatment
    1 Other