BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AB DISTRACT-BODY END ACTIV DISTRACTION-L

    MDR report key: 2936880 · Received January 31, 2013

    Report

    Report Number
    1719045-2013-00231
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    October 20, 2012
    Report Date
    January 7, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQN
    PMA / PMN Number
    K060138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE HAS BEEN RETURNED AND IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ISIMAC MANUFACTURED THE AB DISTRACTOR BODY END ACT., WITH U JOINT, 20MM FOR CMF DISTRACTOR, PART 04.315.054, LOT 6981568. THE SUPPLIER'S CERTIFICATE OF COMPLIANCE, DATED OCTOBER 09, 2012, INDICATES THE LOT WAS PROCESSED PER SPECIFICATIONS, CONFORMED TO SPECIFICATIONS, AND WAS MADE TO THE CORRECT MATERIAL AND HARDNESS REQUIREMENTS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THERE WERE NO COMPLAINT RELATED ANOMALIES, MRRS, OR NCRS ASSOCIATED WITH THIS LOT. THERE WERE NUMEROUS ISIMAC INSPECTION REPORTS, WHICH SPECIFIED 100 PERCENT INSPECTION FOR THE COMPONENT PARTS ASSOCIATED WITH PART 04.315.054. ALL REPORTS INDICATED THE LOT CONFORMED TO SPECIFICATIONS. THE SYNTHES AND ISIMACS FIRST ARTICLE INSPECTION DOCUMENT REVEALED THE DIMENSIONS INSPECTED CONFORMED TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION REPORTED: ARTICLES WERE FORWARDED TO RESPONSIBLE PRODUCT DEVELOPMENT CENTER FOR EVALUATION. THE EVALUATION OF THE DISTRACTOR BODIES AND SCREWS SHOW NO DEFECTS. THE REPORTED ISSUE, IT IS NECESSARY FOR MORE THAN ONE AND A HALF TURNS TO ACTIVATE 1MM, COULD NOT BE CONFIRMED. THE SOFT TISSUE WAS FORWARDED TO AN EXTERNAL INSTITUTE, APPROVED THIRD PARTY FOR A HISTOLOGICAL ANALYSIS. THIS ANALYSIS CONCLUDES: TWO AREAS OF SOFT TISSUE, REPRESENTING ARRAYS OF COLLAGENOUS CONNECTIVE TISSUE WITH ELEMENTS OF VASCULAR INFLAMMATION TYPICALLY FOUND IN THESE AREAS, ARE NOT INDICATIVE OF EITHER A CHRONIC OR ACUTE BACTERIAL FORM. IN ANY CASE, LEUCOCYTES AND ESPECIALLY GRANULOCYTES ARE ALMOST COMPLETELY ABSENT. THE BLACK SPOTS AND ACCUMULATION ARE ALMOST CERTAINLY ABRADED MATERIAL, BUT IT HAS NOT TRIGGERED ANY GIANT CELL REACTION. OBSERVATION AT A COLLAGENOUS CONNECTIVE TISSUE AREA THAT CONTAINS ABUNDANT TITANIUM ABRASION DOES NOT EXHIBIT ANY SIGNS OF INFECTION. THERE IS NO PRODUCT FAILURE DETECTED AND NO FOREIGN BODY REACTION.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATES A HOSPITAL IN (B)(6) REPORTED: THE AB DISTRACTOR BODY DOES NOT DISTRACT AS WELL AS IT SHOULD. DISTRACTOR NEEDS MORE THAN ONE AND A HALF TURNS TO ACTIVATE 1MM. ALSO, IT DOES NOT HOLD THE DISTRACTED LENGTH, RELAPSING, BETWEEN EACH ACTIVATION. SURGEON NOTED IT CAUSES CLINICAL PROBLEMS: MORE X-RAYS, MEDICAL CONSULTATIONS, MORE PAIN DURING DISTRACTION PHASE AND A SECOND SURGERY MUST BE ANTICIPATED. SURGEON SATES HE WILL HAVE TO IMPLANT PLATE FIXATION BILATERY. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42522 AB DISTRACT-BODY END ACTIV DISTRACTION-L AB DISTRACT-BODY END MQN SYNTHES MONUMENT 6981568

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention