BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI HEADLESS COMPRESSION SCREW LNG-THRD/18MM-STERILE

    MDR report key: 4618227 · Received March 19, 2015

    Report

    Report Number
    3000270450-2015-10067
    Event Type
    Injury
    Date Received
    March 19, 2015
    Date of Event
    February 27, 2015
    Report Date
    March 9, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    PK050636
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. THUS, THE DOCUMENTS FOR THE CORRESPONDING NON STERILE PART 04.226.118, LOT 8072755 WERE REVIEWED WITH THE FOLLOWING RESULT: NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    ADDITIONAL NARRATIVE: PATIENT IDENTIFIER, DATE OF BIRTH, AND WEIGHT ARE UNKNOWN. DATE OF POST-OPERATIVE SCREW MIGRATION IS UNKNOWN. 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.

    Description of Event or Problem · 1

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED SCREWS WERE FOUND BACK-OUT POST-OPERATIVELY. THE SCREWS WERE USED FOR THE INITIAL SURGERY OF CAPITULUM OF HUMERUS ON (B)(6) 2015. RE-OPERATION WAS PERFORMED ON (B)(6) 2015. EVENTUALLY, THE RE-OPERATION WAS COMPLETE WITH REMOVAL OF THE REPORTED SCREWS AND BONE FRAGMENT. EXTERNAL FIXATION TO THE AFFECTED PART WAS NECESSARY. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188265 3.0MM TI HEADLESS COMPRESSION SCREW LNG-THRD/18MM-STERILE SCREW,FIXATION,BONE HWC SYNTHES SELZACH 8096920

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention