BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 30MM

    MDR report key: 7016181 · Received November 9, 2017

    Report

    Report Number
    3000270450-2017-10392
    Event Type
    Injury
    Date Received
    November 9, 2017
    Report Date
    October 17, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    KTT
    PMA / PMN Number
    K063049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT¿S IDENTIFIER AND WEIGHT ARE UNKNOWN. DATE OF POST-OPERATIVE INFECTION DEVELOPMENT IS UNKNOWN. ADDITIONAL DEVICE PRODUCT CODES: HRS. (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 202.230S, LOT # 9921636: PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 27.APR.2016, EXPIRY DATE: 01.APR.2026: NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NON-STERILE 202.230 / 9882974 WAS MANUFACTURED IN (B)(4): RELEASE TO WAREHOUSE DATE: 29.MAR.2016: NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    UPDATE PART RETURNED 27 NOV.17. - 06. DEC.17 DURING INITIAL EVALUATION (SEE INVESTIGATION REQUIREMENTS TASK IN (B)(4)) WAS IDENTIFIED THAT THE BACKED-OUT SCREW IS 02.211.044S L426039. IN PART BECAUSE POST-OPERATIVELY, THE PATIENT HAD AN INFECTION. IT IS NOT KNOWN IF THE INFECTION IS DUE TO THE IMPLANT DAMAGE OR OTHER REASONS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AN INITIAL SURGERY WAS PERFORMED ON (B)(6) 2017 AND SCREWS WITH A VARIABLE-ANGLE LOCKING COMPRESSION MEDIAL DISTAL TIBIAL PLATE (VA-LCP) WERE IMPLANTED. POST-OPERATIVELY THE PATIENT HAD AN INFECTION. IT IS NOT KNOWN IF THE INFECTION IS DUE TO THE IMPLANT DAMAGE (CAPTURED UNDER LINKED COMPLAINT (B)(4)) OR OTHER REASONS. REMOVAL SURGERY WILL TAKE PLACE IN 2-3 WEEKS. THIS REPORT IS FOR ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM. THIS IS REPORT 6 OF 13 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793042 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 30MM APPLIANCE, FIXATION, NAIL KTT SYNTHES SELZACH 9921636

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention