BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS SPINE CERVICAL STABILIS.

    MDR report key: 9819497 · Received March 11, 2020

    Report

    Report Number
    9610612-2020-00074
    Event Type
    Injury
    Date Received
    March 11, 2020
    Report Date
    April 28, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    KWQ
    PMA / PMN Number
    K100243
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: DUE TO A LACK OF COMPONENTS, AN INVESTIGATION COULD NOT TAKE PLACE. BECAUSE THE ARTICLE CODE IS STILL UNKNOWN. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NEITHER AN ARTICLE NUMBER NOR A LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS MUST REMAIN INCOMPLETE. CONCLUSION AND ROOT CAUSE: BASED ON THE CURRENT INFORMATION, A CLEAR CONCLUSION CAN NOT BE DRAWN TO DATE. RATIONALE: TO DATE IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE FAILURE. FURTHERMORE THERE ARE NOT ENOUGH INFORMATION REGARDING THE SYSTEM, THE COMPONENTS OR WHETHER IT WAS AN AESCULAP PRODUCT. A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A PRODUCT OF SPINE CERVICAL STABILISATION. THE ARTICLE CODE IS NOT AVAILABLE UNTIL TODAY. INITIAL SURGERY: (B)(6) 2010, DUE TO A ROAD ACCIDENT. THE SURGERY WAS DECOMPRESSION OF T4-T6 AND TO A EXPEDIUM + SUMMIT C5-T12 WITH BARS INSERTING. ON (B)(6) 2010, HE WAS TRANSFERRED TO THE SPINAL UNIT, WITH COMPLETE PARAPLEGIA LEVEL T2 AND SPASMS AT LIMBS OF MODERATE INTENSITY; HE WAS DISMISSED ON (B)(6) 2010. DUE TO FURTHER INVESTIGATIONS ON NOVEMBER 2016 IT WAS HIGHLIGHTED A BREAKAGE OF CONNECTION BETWEEN CERVICAL AND DORSAL PART AND BREAKAGE OF THE BARS. THIS CAUSED AN ADDITIONAL MEDICAL INTERVENTION FOR REMOVING SYNTHESIS PARTS. A REVISION SURGERY WAS NECESSARY. REVISION SURGERY: (B)(6) 2016. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283182 COLLECT.NO.QAS SPINE CERVICAL STABILIS. IMPLANTS CERVICAL STABILISATION KWQ AESCULAP AG AE-QAS-SP40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention