BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTSCR Ø4.5 L28 SST

    MDR report key: 3062523 · Received April 17, 2013

    Report

    Report Number
    8030965-2013-01713
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 21, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE DEVICE HISTORY RECORDS WERE RESEARCHED, NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE DEVICE IN QUESTION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF THIS COMPLAINT IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. IN ADDITION AN ENERGY DISPERSIVE X-RAY SPECTROSCOPY WAS PERFORMED AND IT WAS FOUND THAT THE RESIDUES ON THE PLATE CONSIST OF THE ELEMENTS CARBON, OXYGEN, SULFUR, CALCIUM AND PHOSPHORUS. THIS INDICATES THAT THESE ARE ORGANIC BLOOD AND BONE RESIDUES. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT RETURNED TO THE HOSPITAL IN (B)(6) 2012. SUSPECTED IMPLANT DATE WAS IN (B)(6) 2012 (DATE UNKNOWN). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT PRESENTED WITH TIBIAL PLATEAU FRACTURE WAS TREATED IN (B)(6) 2012 WITH COMPETITORS HARDWARE. PATIENT RETURNED TO THE HOSPITAL IN (B)(6) 2012 DUE TO CONTINUAL PAIN. REPORTEDLY THE COMPETITORS HARDWARE WAS REMOVED AND PATIENT WAS REVISED TO SYNTHES LCP PROXIMAL LATERAL TIBIA PLATE AND SCREW CONSTRUCT. IN (B)(6) 2012 (DATE UNKNOWN), THE PATIENT RETURNED TO THE HOSPITAL DUE TO PAIN THAT HAD BEEN ONGOING SINCE THE OPERATION AND WAS REPORTEDLY GETTING GRADUALLY WORSE. PATIENT ALSO PRESENTED WITH REDNESS ON THE SKIN. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2012 AND SUBSEQUENTLY THE HARDWARE WAS REMOVED. IT WAS REPORTED TESTS WERE PERFORMED AND HISTOLOGY WAS RETURNED WITH EVIDENCE OF PARTICULAR DEBRIS. REPORTEDLY THE SURGEON FEELS THAT THE OVERRIDING PAIN AND REDNESS IS PROBABLY A RESULT OF AN ALLERGIC RESPONSE OR INFECTION BUT IS A LITTLE CONCERNED ABOUT THE EROSION WITHIN THE THREADED HOLES OF THE PLATE AS WELL AS THE PRESENCE OF BLACKENED PARTICLES WHEN THE PLATE WAS REMOVED FROM THE PATIENT. NO EVIDENCE OF OSTEOMYELITIS WAS REPORTED. THIS IS 4 OF 4 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164460 CORTSCR Ø4.5 L28 SST KTT SYNTHES GMBH 3020122

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention