BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNILOCK RECOPL 2.4 ANGL W/COND-HEAD R 18

    MDR report key: 3027140 · Received March 29, 2013

    Report

    Report Number
    2520274-2013-01747
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 1, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    NEI
    PMA / PMN Number
    K990637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO ASIF SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. BASICALLY THE VALUES SHOULD BE IN COMPLIANCE WITH AO ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832-2 FOR TICP. THE FRACTURE FACE OF THE PLATE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. NO PRODUCT FAULT COULD BE DETECTED AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THE ARTICLE NUMBER. BASED ON THE PROVIDED INFORMATION WE SUPPOSE THAT THE PLATE HAD TO ABSORB AND NEUTRALIZE FORCES OVER A LONG PERIOD OF TIME, WHICH CAN LEAD TO A MATERIAL FATIGUE AND FINALLY TO THE BREAKAGE OF AN IMPLANT.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: RECONSTRUCTION SURGERY WAS PERFORMED IN 2011. PATIENT WAS IMPLANTED WITH RECONSTRUCTION PLATE AND SCREWS. AFTER TWO YEARS, THE PLATE WAS FOUND BROKEN; REMOVED: (B)(6) 2013.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130898 UNILOCK RECOPL 2.4 ANGL W/COND-HEAD R 18 NEI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention