BEUDAMED
    FDA Adverse Event Other Summary report: N

    INDUS INVUE TAPERED TIPPED DRIVER

    MDR report key: 2765512 · Received September 20, 2012

    Report

    Report Number
    3005977257-2012-00002
    Event Type
    Other
    Date Received
    September 20, 2012
    Date of Event
    April 11, 2012
    Report Date
    September 12, 2012
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    MRW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE ISSUE IN THIS REPORT IS IDENTICAL TO THE ISSUE IN MDR 3005977257-2012-00001, THE ADD¿L INFO ADDED HERE IS THE SAME AS ON THAT MDR. THE ISSUE WITH THE INDUS INVUE DRIVERS IS THAT THE TIP OF THE DRIVER AND THE HEAD OF THE SCREW DID NOT HAVE A TIGHT ENOUGH FIT. ENGINEERING WORKED SOLUTIONS TO SOLVE THIS ISSUE, WITH THE CONCLUSION BEING THE RELEASE OF AN UPDATED DRIVER WITH A TIP AND SCREW HEAD THAT FIT BETTER. THE ISSUE WITH THE DRIVERS AND SCREWS WAS CLEAR TO SPINEFRONTIER, SO THE SOLUTION WAS ARRIVED AT WITHOUT REVIEWING THE MALFUNCTIONED INSTRUMENT USED IN THIS CASE. ALTHOUGH THIS TYPE OF EVENT IS NOT TYPICALLY REPORTED ON AN MDR, WE ARE SUBMITTING THIS FOR TWO REASONS: THIS EVENT WAS CAPTURED ON A FORM 3500 BY A FORMER EMPLOYEE THAT DID NOT REALIZE THAT THIS EVENT MAY NOT HAVE BEEN REPORTABLE, AND THE ISSUE WITH THIS DRIVER DID RECUR MORE THAN ONE TIME IN THE COMING MONTHS, WHICH NECESSITATED MAKING A CHANGE IN THE DRIVER DESIGN.

    Description of Event or Problem · 1

    PLEASE NOTE, THIS EVENT WAS ERRONEOUSLY FILED ON A FORM 3500 WITH ERRORS ON (B)(6) 2012 BY FORMER PERSONNEL OF SPINEFRONTIER. THIS IS THE CORRECTED VERSION OF EVENTS, ON THE CORRECT FORM 3500A, AND FILED PER DISCUSSION WITH (B)(4) AT THE MDR REPORTING OFFICE OF THE FDA ON 09/11/2012. THIS IS THE IDENTICAL PROBLEM ENCOUNTERED ON MDR 3005977257-2012-00001. SURGEON WAS SURGICALLY IMPLANTING INDUS INVUE ANTERIOR CERVICAL PLATE SYSTEM USING THE TIPPED DRIVER TO INSERT THE FIXATION SCREWS. HE WAS HAVING DIFFICULTY RETAINING THE SCREWS ON THE TIP OF THE DRIVER, WHICH MADE INSERTING THE SCREWS DIFFICULT. THIS DID NOT ADD TIME TO THE SURGERY, OR CAUSE ANY HARM TO THE PT, AS THE SURGEON HAD ANOTHER DRIVER PRESENT TO USE AND COMPLETE THE INSERTION OF THE SCREWS. HOWEVER, IF ANOTHER DRIVER WERE NOT AVAILABLE TO THE SURGEON, THIS COULD HAVE LED TO AN INCREASE IN SURGICAL TIME, PUTTING THE PT AT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDUS INVUE TAPERED TIPPED DRIVER TAPERED TIPPED DRIVER MRW SPINEFRONTIER, INC. 11-70096 012020-001

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR