BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P IMPLANT 7MM HEIGHT LORDOTIC/LARGE-STERILE

    MDR report key: 3083342 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11133
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    July 12, 2012
    Report Date
    July 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 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 ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    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 ON A SUPPLEMENTAL MDR. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ACDF ZERO-P PROCEDURE AT LEVELS C5-C7, THE SURGEON WAS IMPLANTING THE ZERO-P PEEK IMPLANT AT C5-C6. HE HAD THE SPACER PLACED AND HAD ALL THE HOLES DRILLED. WHEN HE WAS PLACING THE LAST SCREW, IT WOULD NOT ENGAGE THE PLATE. HE THEN REDRILLED A NEW HOLE AT A BETTER ANGLE, USED A NEW SCREW WHICH ENGAGED THE HOLE IN THE PLATE CORRECTLY, AND COMPLETED THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT, NO EXTENSION OF TIME. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183395 ZERO-P IMPLANT 7MM HEIGHT LORDOTIC/LARGE-STERILE OVE SYNTHES GMBH 3350221

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR