BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC-STERILE

    MDR report key: 4222666 · Received November 4, 2014

    Report

    Report Number
    1000562954-2014-10201
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 7, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    OVE
    PMA / PMN Number
    PK112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING IMPLANT INSERTION WHILE TAPPING THE IMPLANT HOLDER WITH A MALLET THE PLATE SEPARATED FROM THE CAGE. THE SURGEON WAS UNABLE TO RE-ATTACH THE PLATE; THE SURGEON HAD TO OPEN A SECOND IMPLANT SO THE PROCEDURE COULD BE COMPLETED. THERE WAS NO PATIENT HARM REPORTED. SURGERY WAS REPORTED TO BE PROLONGED ABOUT 2 MINUTES. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705223 ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC-STERILE INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL OVE SYNTHES MEZZOVICO 8979146

    Patients

    Seq Age Sex Outcome Treatment
    1