BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL LOCK-PL 2.4 STRAIG 20HO TI

    MDR report key: 2800388 · Received October 22, 2012

    Report

    Report Number
    2520274-2012-02456
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 24, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K093772
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. ADDED LOT NUMBER. ADDED OPERATOR OF DEVICE. DEVICE MANUFACTURE DATE FOUND TO BE MAY 4, 2010. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. INVESTIGATION COORDINATED BY SYNTHES EUROPE. REPORT RECEIVED INDICATES THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832-2. UNFORTUNATELY THE INFORMATION GIVEN DID NOT PROVIDE SUFFICIENT EVIDENCE FOR AN EXACT DETERMINATION OF THE FAILURE REASON. NEVERTHELESS, A MANUFACTURING RELATED CONDITION CAN BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES GMBH INDICATED A HOSPITAL IN NETHERLANDS REPORTED: PATIENT WAS IMPLANTED WITH STERNAL LOCKING PLATES ON AN UNKNOWN DATE. PATIENT COMPLAINED OF PAIN ON HIS STERNUM. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. DURING THE REMOVAL OF THE PLATES, IT WAS REPORTED THAT THE PLATES APPEARED TO BE BROKEN AT THE INTERLOCKING PART. THERE WAS NO SIGHT OF PLATE FRACTURE ON THE X-RAYS TAKEN ON AN UNKNOWN DATE. PATIENTS BONE DID HEAL. THIS IS #2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERNAL LOCK-PL 2.4 STRAIG 20HO TI STERNAL LOCKING PLATE HRS SYNTHES USA 6383137

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATE