BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2971001 · Received February 21, 2013

    Report

    Report Number
    2520274-2013-01059
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS IMPLANTED WITH SYNTHES CONDYLAR PLATE AND ONE 1.5MM CORTEX SCREW WAS IMPLANTED. THE OTHER FIVE SCREWS WERE COMPETITORS 2.0MM SCREWS VARYING IN LENGTH. SYNTHES USA IS RETRACTING THIS MW REPORT # 2520274-2013-01058 AS THE REPORTED DEVICE IS NOT MANUFACTURED BY SYNTHES.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE COMPLAINT DESCRIBES HAVING TO REMOVE THE PLATE AND SCREWS DUE TO A NON-UNION. THERE IS NO INFORMATION ABOUT WHERE THE PLATE WAS USED OR FOR HOW LONG THE PLATE WAS IMPLANTED. THERE IS NO DAMAGE SEEN TO THE PLATE AND ONLY THE STARDRIVE RECESS LOOKS SLIGHTLY DEFORMED IN THE SINGLE SCREW RETURNED. THE PLATE IS DESIGNED USING ES STANDARDS FOR LCP HOLES AND SPECIFIES 316L STAINLESS STEEL FOR MATERIAL. THE RISK ASSESSMENT DOES ADDRESS CHOOSING AN INCORRECT IMPLANT WHICH COULD LEAD TO A NON-UNION. THERE WAS A NON-UNION BUT IT IS UNKNOWN WHAT THE FRACTURE WAS OR FOR HOW LONG THE PLATE WAS IMPLANTED. THE DESIGN IS APPROPRIATE FOR ITS INDICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. (B)(6): INFORMATION FROM RECEIVED QUESTIONNAIRE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH LCP CONDYLAR PLATE AND SCREWS ON AN UNKNOWN DATE. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 FOR REVISION SURGERY DUE TO NON-UNION. ONE PLATE AND SIX SCREWS WERE REMOVED. PATIENT WAS REVISED TO ANOTHER PLATE AND SCREW CONSTRUCT. THIS IS 4 OF 7 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS 4 OF 7 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76760 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention