BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO-P LRG LORDOTIC H7 PEEK

    MDR report key: 2944882 · Received February 6, 2013

    Report

    Report Number
    8030965-2013-00329
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 3, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE IMPLANT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE MEASURABLE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO ASIF SPECIFICATIONS. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF FAILURE AND CAN ONLY ASSUME THAT APPLIED BENDING AND, OR TORSIONAL FORCES DURING THE INSERTION CAUSED THIS SEPARATING OF THIS IMPLANT. ANOTHER POSSIBLE REASON WOULD BE TOO HIGH LATERAL STRESS WHILE THE IMPLANT HOLDER WAS REMOVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: SURGEON WAS IMPLANTING A CAGE AND SCREW CONSTRUCT ON (B)(6) 2012. DURING INSERTION OF THE SECOND SCREW, THE IMPLANT SPLIT INTO TWO PARTS INSIDE OF THE PATIENT. THE SURGEON REMOVED THE IMPLANT AND FINISHED THE PROCEDURE USING A COMPETITORS CAGE. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50395 ZERO-P LRG LORDOTIC H7 PEEK CAGE OVE SYNTHES GMBH 3459647

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention