BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO-P IMPLANT 7MM HEIGHT LORDOTIC-STERILE

    MDR report key: 3013247 · Received March 20, 2013

    Report

    Report Number
    8030965-2013-01011
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K072981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH ZERO-P HARDWARE ON (B)(6) 2012. DURING A FOLLOW UP APPOINTMENT, ABOUT ONE MONTH POST-OPERATIVE, SURGEON FOUND THAT ONE LOCKING SCREW AT LEVEL C5-C6 HAD BACKED OUT. PATIENT WAS ASYMPTOMATIC AND WOULD BE MONITORED, AND SURGEON DID NOT PLAN A REVISION AT THIS TIME. PATIENT RETURNED TO THE SURGEON ON AN UNKNOWN DATE, COMPLAINING THAT THE PREVIOUSLY REPORTED BACKED OUT SCREW WAS NOW CAUSING DISCOMFORT AND SHE WANTED IT REMOVED. PATIENT RETURNED TO THE O.R. ON (B)(6) 2013 AND SURGEON REMOVED ONE 3MM CERVICAL SPINE LOCKING SCREW FROM C6 LEFT SIDE. ALL OTHER HARDWARE REMAINED IMPLANTED. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116124 ZERO-P IMPLANT 7MM HEIGHT LORDOTIC-STERILE OVE SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention