BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM TI CURVED ROD 40MM

    MDR report key: 3030704 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-01274
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. BASED ON THE DESCRIPTION, THE SALES CONSULTANT SUBMITTED THIS COMPLAINT DUE TO A PATIENT INFECTION RESULTING IN A REVISION SURGERY. THE DRAWINGS FOR ALL THE IMPLANTS REQUIRE IMPLANT GRADE MATERIAL AND ACCEPTABLE FINISHING PROCESSES. THE SURGEON REMOVED THE POSTERIOR CONSTRUCT SUCCESSFULLY. A PRODUCT DEVELOPMENT EVALUATION CAN NOT DETERMINE THE ROOT CAUSE OF THE PATIENT INFECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. (B)(6).

    Description of Event or Problem · 1

    THIS IS 4 OF 9 REPORTS FOR (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH MATRIX SYSTEM AT LEVELS L5-S1 DUE TO DEGENERATIVE DISC DISEASE ON (B)(6) 2012. POST-OPERATIVELY, ON AN UNKNOWN DATE, PATIENT DEVELOPED DETERIORATION AND A LINGERING INFECTION, WHICH WOULD NOT HEAL, AT IMPLANT SITE. PATIENT RETURNED TO THE O.R ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. SURGEON REMOVED ALL HARDWARE EXCEPT FOR ONE TRANS INTERBODY OPAL SPACER WHICH STILL REMAINS IN PATIENT AT LEVELS L5-S1. THE SURGEON REMARKED THAT AREA LOOKED GOOD UPON REMOVAL OF PARTS. PATIENT WAS TREATED WITH ANTIBIOTIC BEADS ORALLY FOR THE INFECTION. THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS 4 OF 9 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134101 5.5MM TI CURVED ROD 40MM NKB SYNTHES GMBH 3780618

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention