BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P CONVEX H5 PEEK

    MDR report key: 2854995 · Received December 3, 2012

    Report

    Report Number
    8030965-2012-01425
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 5, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K073541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THIS DEVICE WAS USED FOR TREATMENT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS IMPLANT WAS MANUFACTURED IN JUNE 2011 ACCORDING TO THE SPECIFICATIONS. NO ABNORMAL FINDINGS WERE IDENTIFIED. THE MEASURABLE DIMENSIONS WERE CHECKED AND FOUND TO CONFORM TO THE DRAWINGS AND AO/ASIF SPECIFICATIONS. THE EXACT CAUSE OF FAILURE COULD NOT BE DETERMINED, WE CAN ONLY ASSUME THAT EXCESSIVE BENDING OR TORSION FORCES LED TO THE SEPARATION OF THE PLATE FROM THE CAGE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING A PROCEDURE A ZERO-P CAGE/PLATE FELL APART DURING INSERTION. THE ZERO-P WAS REMOVED AND THE SURGERY WAS COMPLETED WITH ANOTHER ZERO-P IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO-P CONVEX H5 PEEK ZERO-P CONVEX H5 PEEK OVE SYNTHES GMBH 7500081

    Patients

    Seq Age Sex Outcome Treatment
    1