BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI SCHANZ SCREW WITH DUAL CORE 45MM THREAD/190MM

    MDR report key: 7506158 · Received May 11, 2018

    Report

    Report Number
    8030965-2018-53684
    Event Type
    Injury
    Date Received
    May 11, 2018
    Report Date
    April 20, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: UDI. 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.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. DATE OF EVENT IS UNKNOWN. ADDITIONAL PROCODES: MNI, MNH, KWP, KWO. DEVICE WAS NOT EXPLANTED. REPORTER EMAIL ADDRESS IS UNAVAILABLE. PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: PART NO.: 496.713S. LOT NO.: L384524 . MANUFACTURING LOCATION: (B)(6). SUPPLIER: (B)(6). RELEASE TO WAREHOUSE DATE: 19.APR.2017. EXPIRY DATE: 01.APR.2027. NO NONCONFORMACE RECORDS (NCR) 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 496.713 / 9090760 WAS MANUFACTURED IN (B)(4). RELEASE TO WAREHOUSE DATE: 05.AUG.2014. 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. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, A SURGERY FOR BURST FRACTURE AT L4 WAS PERFORMED USING THE UNIVERSAL SPINE SYSTEM (USS) FRACTURE SYSTEM. THE FIXED AREA WAS L3 ¿ L5. ON (B)(6) 2018, THE BREAKAGE OF THE REPORTED SCREW WAS CONFIRMED AT L3 UNDER THE X-RAY, AND NON-UNION WAS ALSO OBSERVED. IT IS UNKNOWN WHEN THE BREAKAGE HAPPENED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 5.0MM TI SCHANZ SCREW WITH DUAL CORE 45MM THREAD/190MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351234 5.0MM TI SCHANZ SCREW WITH DUAL CORE 45MM THREAD/190MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB OBERDORF SYNTHES PRODUKTIONS GMBH L384524

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention