BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTSCR Ø4.5 L46 SST

    MDR report key: 3023920 · Received March 27, 2013

    Report

    Report Number
    2520274-2013-01725
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 28, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS.THE EXAMINATION OF THE MANUFACTURER DOCUMENTS, TECHNICAL DRAWINGS AND RAW-MATERIAL INSPECTION SHEET SHOWED THAT THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES ARE IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS. THE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS OF THE PRODUCER AND AO/ASIF SPECIFICATIONS. THE FAILURE WAS DUE TO DYNAMIC BENDING WHICH LED TO THE MATERIAL FATIGUE. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES WE CAN CONCLUDE THAT THE IMPLANT HAD TO ABSORB AND NEUTRALIZE FORCES THAT HAVE BEEN GREATER THAN THE TOLERABLE LOAD. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH PLATE AND SCREW CONSTRUCT ON (B)(6) 2013 FOR FEMORAL NECK FRACTURE. IT IS REPORTED THAT ON (B)(6) 2013 TWO CORTEX SCREWS BROKE. PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 AND HARDWARE WAS REMOVED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR AN UNKNOWN 4.5 CORTEX SCREW. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS 1 OF 3 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125260 CORTSCR Ø4.5 L46 SST HWC SYNTHES GMBH 2765891

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention