BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XRL LARGE CENTRAL BODY 29MM-39MM HEIGHT-STERILE

    MDR report key: 3812662 · Received May 15, 2014

    Report

    Report Number
    1719045-2014-10202
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQP
    PMA / PMN Number
    PK103320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT EVALUATION WAS PERFORMED. (B)(4). 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

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.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

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE XRL LARGE CENTRAL BODY WAS ASSEMBLED AND STERILIZED PER WORK ORDER. THIS LOT WAS ASSEMBLED FROM COMPONENT LOT 6856213. THE COMPONENTS WERE MANUFACTURED BY RMS COMPANY FOR BRANDYWINE. THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE INDICATES THAT THE PARTS MET ALL REQUIRED SPECIFICATIONS. THE PARTS WERE INSPECTED TO SYNTHES INSPECTION SHEET. THERE WERE NO NON-CONFORMANCE RECORDS GENERATED FOR THIS LOT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A T12 CORPECTOMY WITH A LATERAL FUSION OF T11-L1 PROCEDURE AN EXPANDABLE CAGE¿S VISUAL KEY WOULD NOT LOCK PROPERLY DURING THE SURGERY. THE SURGEON HAD PACKED THE CAGE WITH BONE GRAFT FROM THE RIB AND CORPECTOMY SITE. THE DEVICE WAS EXTRACTED, EXPANDED AND PLACED IN THE PATIENT AGAIN; IT WAS THEN REPORTED THE SURGEON TRIED TO OPEN AND CLOSE THE CAGE MULTIPLE TIMES AND THE DEVICE WOULD NOT APPEAR TO BE LOCKED. THE SURGEON THEN USED ANOTHER EXPANDABLE CAGE AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS A TIME DELAY OF FIFTEEN TO TWENTY MINUTES. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290458 XRL LARGE CENTRAL BODY 29MM-39MM HEIGHT-STERILE SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SYNTHES MONUMENT 6901403

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR