BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO-P IMPLANT 6MM

    MDR report key: 2960774 · Received February 11, 2013

    Report

    Report Number
    8030965-2013-10023
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K073541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO A FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED IN A SUPPLEMENTAL MDR. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE ZERO-P IMPLANT REVEALED NO ISSUES RELATED TO THE REPORTED EVENT. PLATE DIMENSIONS NOT AFFECTED BY THE REPORTED ISSUE WERE FOUND WITHIN SPECIFICATION. NON-TRIVIAL ABRASION MARKS WERE OBSERVED ON THE PLATE AT THE THREADED INSERTS POTENTIALLY DEMONSTRATING NON-AXIAL INSERTION OF SCREWS. BASED ON THE EVIDENCE PROVIDED THROUGH VISUAL EXAMINATION IT IS REPORTED THAT THE EVENT COULD HAVE RESULTED FROM AN ATTEMPT AND/OR ATTEMPTS TO INSERT LOCKING SCREWS IN THE ZERO-P IMPLANT AT INCORRECT ANGLES. NO EVIDENCE OF A DEFICIENCY IN THE ZERO-P IMPLANT DESIGN OR MANUFACTURING WAS IDENTIFIED. AT THIS TIME ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING AN ACDF AT LEVELS C4-C5, TWO OF THE HOLES IN ZERO-P IMPLANT WOULD NOT PROPERLY ENGAGE THE SCREWS, AND THE SCREWS WOULD NOT LOCK CORRECTLY TO THE PLATE. THE SURGEON REMOVED THE ZERO-P IMPLANT AND SCREWS AND USED NEW PRODUCTS TO COMPLETE THE PROCEDURE. TWENTY MINUTES WERE ADDED TO THE PROCEDURE. THIS IS 1 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60005 ZERO-P IMPLANT 6MM OVE SYNTHES GMBH 3712185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention