BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC-STERILE

    MDR report key: 3020704 · Received March 26, 2013

    Report

    Report Number
    8030965-2013-10629
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    April 19, 2012
    Report Date
    April 19, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ZERO-P IMPLANTATION AT C6-7, SURGEON INSERTED THE IMPLANT, LOT 7755852 AND THE LOCKING MECHANISM WOULD NOT LOCK. SURGEON USED THE SCREW REMOVAL TOOL TO REMOVE THE IMPLANT, SURGEON THEN FLIPPED THE IMPLANT RE-INSERTED AND THE LOCKING MECHANISM WOULD NOT LOCK. THE SURGEON SELECTED ANOTHER IMPLANT LOT 3537843. AT THE INSERTION OF THE SECOND SCREW, THE SCREW AND PLATE SEPARATED FROM THE PEEK. SURGEON REMOVED THE ZERO-P IMPLANT BY HAND AND SELECTED ANOTHER LARGER ZERO-P IMPLANT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS. THE PROCEDURE WAS EXTENDED ABOUT 20 MINUTES WITH NO REPORT OF PATIENT DISTRESS. DURING THE REMOVAL OF THE SCREW, THE INNER SHAFT OF THE INNER SHAFT FOR REMOVAL SCREWDRIVER BENT, AND ONE 3.7MM TI CERVICAL SPINE SCREW WAS DAMAGED. THIS IS REPORT 2 OF 3 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 3 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123136 ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC-STERILE OVE SYNTHES GMBH 3537843

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention