BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLIP PISTON MVP

    MDR report key: 2093872 · Received April 21, 2011

    Report

    Report Number
    8010617-2011-00001
    Event Type
    Other
    Date Received
    April 21, 2011
    Manufacturer
    HEINZ KURZ GMBH MEDIZINTECHNIK
    Product Code
    ETA
    PMA / PMN Number
    K042503
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    POTENTIAL RISK: WHEN SELECTING THE IMPLANT LENGTH FOR A SURGICAL PROCEDURE ON THE BASIS OF THE 6.5 MM SIZE INDICATED ON THE FLAP TEAR, THE IMPLANT MAY NOT REACH FAR ENOUGH INTO THE PERILYMPHATIC SPACE TO ACHIEVE OPTIMAL SOUND TRANSFER. THE RESULTING LACK OF HEARING GAIN MAY MAKE REVISION SURGERY NECESSARY. MANUFACTURER COMMENT: THE CLIP PISTON MVP IS DESIGNED TO CONNECT THE MALLEUS HANDLE WITH THE INNER EAR. THE BALL JOINT IN THE SHAFT MAKES THE IMPLANT UNIQUELY BENDABLE TO FACILITATE ADJUSTMENT TO THE PT'S ANATOMICAL SITUATION. IT IS EXPECTED THAT THE SURGEON WOULD IMMEDIATELY RECOGNIZE THAT THE 0.75 MM SHORTER IMPLANT (5.75MM INSTEAD OF 6.5 MM) DOES NOT REACH THE PERILYMPHATIC SPACE. THEREFORE, THE RISK THAT SUCH AN IMPLANT WOULD ACTUALLY BE SURGICALLY PLACED, APPEARS TO BE VERY LOW. RECALL: NEVERTHELESS, THE MFR HAS DECIDED TO INITIATE A COMPLETE RECALL OF THE 32 DEVICES PRODUCED WITH LOT 2091306. ACCORDING TO OUR RECORDS, ONLY EIGHT (8) OF THESE DEVICES WERE SOLD IN THE USA. THE RECALL PROCEDURES COMMENCE TODAY,(B)(4) 2011 AND ARE EXPECTED TO BE COMPLETED BY (B)(4) 2011. A FINAL REPORT WILL BE SUBMITTED APPROX (B)(6) MONTH(S) LATER. CAPA: TO PREVENT THE OCCURRENCE OF SUCH MISLABELING IN THE FUTURE, KURZ HAS INITIATED CORRECTIVE ACTIONS AFFECTING THE PACKAGE LABELS AND RELATED VERIFICATION PROCEDURES REGARDING ALL OF THEIR MIDDLE EAR IMPLANTS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, HEALTH PROFESSIONALS AT (B)(6), DISCOVERED A DISCREPANCY IN IMPLANT SIZE LABELING ON THE PACKAGE OF THE CLIP PISTON MVP TITANIUM IMPLANT. THE SIZE WAS PROPERLY LABELED AS DIA. 0.4 X 5.75 MM ON THE FRONT OUTSIDE OF THE PACKAGE, THE PT/HOSPITAL LABELS ON THE INSIDE AND ON THE PRIMARY PACKAGE CONTAINING THE STERILE IMPLANT. HOWEVER, ON THE TEAR FLAP ON THE SIDE, THE SIZE WAS INDICATED AS DIA. 0.4 X 6.5 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLIP PISTON MVP TOTAL OSSICULAR PROSTHESIS ETA HEINZ KURZ GMBH MEDIZINTECHNIK 1006 711 2091306

    Patients

    Seq Age Sex Outcome Treatment
    1