BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI ALVEOLAR DISTRACTOR WITH STRAIGHT PLATE 12MM

    MDR report key: 5196760 · Received November 3, 2015

    Report

    Report Number
    1000562954-2015-10198
    Event Type
    Malfunction
    Date Received
    November 3, 2015
    Date of Event
    October 19, 2015
    Report Date
    October 19, 2015
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    MQN
    PMA / PMN Number
    PK043555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE INVESTIGATION SUMMARY ¿ INVESTIGATION DONE ON: TWO (2) 488.075 / LOT NO.: 9123662 / ALVEOLAR DISTRACTOR DISTRACTION-L 12 TI. ONE (1) 488.075 / LOT NO.: 9123664 / ALVEOLAR DISTRACTOR DISTRACTION-L 12 TI. THE THREE DEVICES ARE BLOCKED AND DO NOT FUNCTION ANYMORE. THE MICROSCOPIC INVESTIGATION SHOWS DEFORMATION IN VARIOUS AREAS CAUSED DURING POST MANUFACTURING APPLIED MECHANICAL OVERLOADING. THE SPINDLES HAVE BEEN MEASURED AND ALL FEATURES WERE FOUND TO MEET THE SPECIFICATIONS. BECAUSE OF THE DAMAGE THE CONTACT AREAS OF THE BLOCKED COMPONENTS CANNOT BE CHECKED TO THE SPECIFICATIONS. FROM VISUAL INSPECTION THE 3 PIECES ARE SLIGHTLY DEFORMED, LIKELY DUE TO THE FORCE APPLIED DURING USE. THE SCREW RESPONSIBLE FOR THE MOVEMENT HAS BEEN MEASURED. THE CORE DIAMETERS AND THE MAIN CHARACTERISTICS OF THE THREE SCREWS WERE FOUND CONFORMING TO SPECIFICATION. THE POINT WHERE THE COMPONENTS ARE BLOCKED COULD NOT BE MEASURED SINCE THE PARTS MUST BE DESTROYED AND THIS COULD AFFECT THE COMPONENTS. THE DISPOSITION OF THE COMPLAINT MANUFACTURING INVESTIGATION IS INDETERMINATE. THE DHR REVIEWS SHOW THAT THE DEVICES MET THE SPECIFICATIONS AT THE TIME OF MANUFACTURING AND DISTRIBUTING. THESE DEVICES ARE SUBJECT OF A 100% INSPECTION PROCEDURE DURING MANUFACTURING, ASSEMBLING AND THE FINAL INSPECTION. A FINAL MANUFACTURING CONCLUSION CANNOT BE PRESENTED DUE TO THE CONDITION OF THE PRODUCTS. VISUALLY THERE DOES NOT APPEAR TO BE AN ISSUE OTHER THAN THE DAMAGE SUSTAINED BY MECHANICAL OVERLOADING. THE FUNCTIONALITY OF THE PARTS WAS TESTED 3 TIMES ON 100% OF THE PARTS BEFORE RELEASE AND NO ANOMALIES WERE FOUND. THE CONTROLS IN PLACE ARE ROBUST ENOUGH TO PROOF THAT THE PARTS WERE MANUFACTURED CONFORMING TO THE SPECIFICATIONS. AS IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT, DEVICE WAS NOT IMPLANTED / EXPLANTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT REPORTED. IMPLANT/EXPLANT DATES: UNKNOWN. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 22 AUGUST 2014, NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS INITIALLY REPORTED THAT THREE (3) UNITS OF THE SAME LOT NUMBER WERE AFFECTED. WHILE THE CORRECT NUMBER OF IMPACTED DEVICES WAS REPORTED, IT WAS DETERMINED THAT TWO (2) DEVICES OF THE SAME LOT (9123664) WERE COMBINED INTO ONE REPORT AND ONE DEVICE HAD A DIFFERENT LOT NUMBER. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TRANSPORT PLATE WAS UNABLE TO MOVE UP. THE DISTRACTOR IS VERY TIGHT AND UNABLE TO OPEN UP THE SPACE. THREE UNITS OF THE SAME LOT NUMBER WERE AFFECTED. NO PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728196 TI ALVEOLAR DISTRACTOR WITH STRAIGHT PLATE 12MM MANDIBLE DISTRACTION DEVICES MQN SYNTHES MEZZOVICO 9123664

    Patients

    Seq Age Sex Outcome Treatment
    1