BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANGORS POSTERIOR SYSTEM

    MDR report key: 1890166 · Received October 29, 2010

    Report

    Report Number
    9612420-2010-00003
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    August 25, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ULRICH GMBH & CO. KG
    Product Code
    NKB
    PMA / PMN Number
    K052385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER VIEWING THE PRODUCTION ORDER AND MATERIAL CERTIFICATES OF AFFECTED IMPLANTS, NO DEVIATION WAS FOUND FROM THE SPECIFICATIONS. THE EXPLANTS SHOWED A VIOLENT RUPTURE IN THE PERFORATION HOLES AND BELOW THE SCREW HEAD. MICROSCOPIC EXAMINATION AND MEASUREMENT OF THE EXPLANTS WAS NOT POSSIBLE, AS THESE ARE RETAINED BY THE HOSPITAL. ACCORDING TO INFORMATION PROVIDED BY THE ATTENDING DOCTORS OF THE CLINIC, IT WAS REPORTED ON THE CASE OF A (B)(6) FEMALE PATIENT ((B)(6)), WHICH WAS IN CLINICS IN (B)(6) 2010 DUE TO A DEGENERATIVE SPONDYLOLISTHESIS L5/S1 AND OTHER CHANGES, SHE WAS STABILIZED FROM L3 TO S1 FOR THE FIRST TIME. A SCREW BREAKAGE IN S1 IN (B)(6) 2010 REQUIRED A FIRST REVISION SURGERY. RE-SCREW BREAKAGE IN BOTH SIDES S1 IN (B)(6) 2010 FORCED FURTHER REVISION. DIAGNOSIS AND SURGICAL TREATMENT WERE JUST REGULAR, ACCORDING TO THE TREATING PHYSICIANS. THE PATIENT HAS NOW BEEN SUPPLIED WITH A BRACE AFTER SURGERY AND PRESCRIBED AN INCREASED PHYSICAL PROTECTION. THE IMPLANT FAILURE WAS DESCRIBED AS AN UNFORTUNATE CONSEQUENCE OF AN UNEXPLAINED CONSTELLATION AT (B)(6) AND SEVERELY REDUCED BONE MASS. THE INVESTIGATION OF THE IMPLANTS SHOWED NO DEVIATIONS FROM THE SPECIFICATIONS. IMPLANT FAILURE CANNOT BE ENTIRELY EXCLUDED. OUR INSTRUCTION FOR USE POINTS OUT THE POSSIBILITY OF IMPLANT FAILURE AS A POSTOPERATIVE COMPLICATION.

    Description of Event or Problem · 1

    PEDICLE SCREW BREAKAGE AT S1 BOTH SIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANGORS POSTERIOR SYSTEM NKB (MNH,MNI) NKB ULRICH GMBH & CO. KG WS14703921/14707167

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention