BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.3MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM

    MDR report key: 5072241 · Received September 11, 2015

    Report

    Report Number
    2520274-2015-15818
    Event Type
    Injury
    Date Received
    September 11, 2015
    Report Date
    April 1, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    DZL
    PMA / PMN Number
    PK983485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SYNTHES WAS MADE AWARE OF THE EVENT ON (B)(4) 2015; HOWEVER, SYNTHES WAS NOT AWARE OF THIS DEVICE UNTIL ITS RECEIPT ON (B)(4) 2015. THE ACTUAL DATE OF IMPLANT MAY HAVE BEEN (B)(6) 2015. IT IS UNKNOWN WHICH OF THE REPORTED SCREWS WHERE IMPLANTED ON WHICH OF THE REPORTED DATES. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS AND WILL BE ADDRESSED AND REPORTED UNDER (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FOLLOW-UP VISIT AFTER HAVING A DISTRACTOR IMPLANTED ON (B)(6) 2015 AND THE SUBSEQUENT IMPLANTATION OF 6 ADDITIONAL SCREWS ON (B)(6) 2015. THE DETAILS OF THIS FIRST REVISION SURGERY ARE ADDRESSED AND WERE REPORTED UNDER THE RELATED COMPLAINT, (B)(4). DURING THE FOLLOW-UP VISIT THE SURGEON NOTICED THE DEVELOPMENT OF A STAPHYLOCOCCAL INFECTION. THE SURGEON ALSO NOTICED DIFFICULTY WITH THE LEFT SIDE DISTRACTOR TURNING AND MOVING. THE PATIENT UNDERWENT ANTIBIOTIC TREATMENT AND THE SURGEON PLANNED TO REMOVE THE DISTRACTOR AFTER THE INFECTION WAS RESOLVED. THE RIGHT SIDE DISTRACTION WAS COMPLETED AND HAS REACHED TREATMENT OBJECTIVES. THE SURGEON SCHEDULED THE HARDWARE EXPLANT/REVISION SURGERY ON (B)(6) 2015 AND THE HARDWARE WAS REMOVED. THIS COMPLAINT ADDRESSES THE OCCURRENCE OF INFECTION. CONDITIONS DISCOVERED DURING THE EXPLANT SURGERY, DETAILS OF THE REVISION SURGERY AND THE SUBSEQUENT PATIENT TREATMENT ARE ADDRESSED UNDER RELATED COMPLAINT (B)(4). THE RECEIPT AND EVALUATION OF THE COMPLAINED DEVICES WILL ALSO BE ADDRESSED UNDER THE RELATED COMPLAINT (B)(4). THIS REPORT IS 17 OF 21 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602809 1.3MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM SCREW FIXATION INTRAOSSEOUS DZL SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention