BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALVEOLAR DISTRACTOR DISTRACTION-L 16 TI

    MDR report key: 2954692 · Received February 11, 2013

    Report

    Report Number
    8030965-2013-00383
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQN
    PMA / PMN Number
    K043555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS WERE 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 SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH UND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. THE FRACTURE FACE OF THE SPINDLE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. NO PRODUCT FAULT COULD BE DETECTED. THE COMPLAINED MALFUNCTION WAS CAUSED BY A BROKEN SPINDLE. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. WE CAN ONLY ASSUME THAT TOO MUCH TORQUE WAS APPLIED WITH THE ACTIVATION INSTRUMENT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN SPAIN AS FOLLOWS: THE DISTRACTOR MECHANISM DID NOT WORK DURING THE SURGERY. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58130 ALVEOLAR DISTRACTOR DISTRACTION-L 16 TI DISTRACTOR MQN SYNTHES GMBH 3535608

    Patients

    Seq Age Sex Outcome Treatment
    1