BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT CENTROLOCK LEFT - STEP 4

    MDR report key: 10586212 · Received September 25, 2020

    Report

    Report Number
    3010673777-2020-00002
    Event Type
    Injury
    Date Received
    September 25, 2020
    Date of Event
    June 23, 2020
    Report Date
    July 10, 2020
    Manufacturer
    NOVASTEP
    Product Code
    HRS
    UDI-DI
    03700879511849
    PMA / PMN Number
    K192356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION : THE INVESTIGATIONS REVEALED 2 MAJOR MISTAKES: -THE SURGEON HASN'T FOLLOWED THE OPERATIVE TECHNIQUE: HE'S USED A NON LOCKING SCREW INSTEAD OF A LOCKING SCREW -THE PATIENT HAS NOT FOLLOWED THE SURGEON'S RECOMMENDATION: HE HAS RETURNED TO HIS PROFESSIONAL ACTIVITIES SOONER THAN ADVISED. THE COMBINATION OF BOTH ELEMENTS MAY EXPLAIN THIS BREAKAGE, DUE TO A NON-RESPECT OF THE PRODUCTS INDICATION FOR USE. THE DHR OF THE DIFFERENT IMPLIED DEVICES DID NOT REVEAL ANY DISCREPANCY AGAINST THE SPECIFICATIONS. CONSEQUENTLY, NO COMPLEMENTARY ACTION IS REQUIRED. INITIAL MDR SENT ON THE 7TH OF JULY 2020. REMARK : ACKNOWLEDGEMENT AVAILABLE IN THE WEBTRADER BASIS, BUT THE INCIDENT IS NOT VISIBLE IN THE MAUDE BASIS. TRIAL TO SEND AN UPDATE OF THIS MDR ON THE (B)(6) 2020 : SUBMISSION RESULT => "THE INITIAL REPORT IS MISSING". DUE TO THIS ISSUE, THIS UPDATE HAS BEEN PASSED ON AN INITIAL SUBMISSION.

    Description of Event or Problem · 1

    INITIAL INFORMATION RETRIEVED BY PHONE ON THE 23TH OF JUNE 2020. ADDITIONAL INFORMATION HEREAFTER, DATED OF THE (B)(6) 2020 : « IMPLANT BROKE POST OPERATIVELY. PATIENT WORKS CONSTRUCTION & RETURNED TO NORMAL ACTIVITY SOONER THAN ADVISED BY THE PHYSICIAN. PATIENT SAID HE HEARD THE IMPLANT BREAK AS HE WAS ON THE JOB ». TRACEABILITY DATA RETRIEVED ON THE (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054442 IMPLANT CENTROLOCK LEFT - STEP 4 IMPLANT HRS NOVASTEP IMPLANT CENTROLOCK LEFT - STEP 4 H00255 03700879511849

    Patients

    Seq Age Sex Outcome Treatment
    1 Other