BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM CORTEX SCREW SLF-TPING WITH T4 STARDRIVE RECESS 12MM

    MDR report key: 2971022 · Received February 21, 2013

    Report

    Report Number
    2520274-2013-01057
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. (B)(6): INFORMATION FROM RECEIVED QUESTIONNAIRE. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A SINGLE SCREW WAS RETURNED WITH THE SUBTASK ASSOCIATED WITH THIS COMPLAINT. NO PART NOR LOT NUMBERS WERE PROVIDED. THE SCREW IS WHOLE AND INTACT. THE GENERAL FEATURES THAT INCLUDE STAINLESS STEEL, 1.5MM MAJOR DIAMETER, SELF-TAPPING, STARDRIVE CORTEX SCREW SUGGEST THAT THIS MAY BE OF THE 02.214.1XX FAMILY OF SCREWS. IF SO, THE LENGTH OF 12.3 WOULD MAKE THIS A 02.214.112. THE DRIVE HAS BEEN HEAVILY DAMAGED. ALL OF THE DRIVE LOBES HAVE BEEN DISPLACED WITH METAL ALSO DISPLACED ONTO THE TOP OF THE HEAD. THIS METAL DISPLACEMENT AFFECTS HEAD PROFILE. THE REMAINDER OF THE HEAD IS IN RELATIVELY GOOD CONDITION. THE SECOND SHAFT THREAD HAS BEEN SLIGHTLY BENT AND AFFECTS THREAD PROFILE. THE REMAINDER OF THE SHAFT THREADS IS IN GOOD CONDITION, AS ARE THE FLUTES AND THE TIP. THE DIMENSIONS THAT COULD BE MEASURED ARE WITHIN SPECIFICATION. DUE TO THE TYPE AND EXTENT OF DAMAGED INCURRED, AND ALSO BECAUSE NO PART NOR LOT NUMBERS WERE PROVIDED, A FINITE EVALUATION WAS NOT POSSIBLE.

    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.

    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.

    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 2 OF 7 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH LCP CONDYLAR PLATE AND SIX SCREWS. OF THE SIX SCREWS, ONLY ONE WAS SYNTHES HARDWARE. THE REMAINING FIVE SCREWS WERE COMPETITORS HARDWARE. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4) .

    Description of Event or Problem · 1

    THIS IS 2 OF 7 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76826 1.5MM CORTEX SCREW SLF-TPING WITH T4 STARDRIVE RECESS 12MM SCREW HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention COMPETITORS 2.0MM SCREWS