BEUDAMED
    FDA Adverse Event Injury Summary report: N

    130 DEG LCP DHS PLATE-STANDARD BARREL 10 HOLES/188MM-STERILE

    MDR report key: 4730633 · Received April 27, 2015

    Report

    Report Number
    3000270450-2015-10094
    Event Type
    Injury
    Date Received
    April 27, 2015
    Report Date
    April 10, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT INFORMATION: THE PATIENT¿S HEIGHT WAS REPORTED AS 166CM. DATE OF POST-OPERATIVE DEVICE BREAKAGE IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE US. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: MANUFACTURING LOCATION: (B)(4)- MANUFACTURING DATE: JANUARY 29, 2013 - EXPIRY DATE: JANUARY 1, 2023. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. THUS, THE DOCUMENTS FOR THE CORRESPONDING NON-STERILE PART (02.224.210 / LOT 8212156) WERE REVIEWED WITH THE FOLLOWING RESULTS: NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NON-CONFORMANCE REPORTS 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. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE PLATE BROKE POST-OPERATIVELY, REQUIRING A REVISION PROCEDURE WHICH TOOK PLACE ON (B)(6) 2015. THE BROKEN PLATE WAS REMOVED. THE PROCEDURE WAS DELAYED BY APPROXIMATELY SIXTY (60) MINUTES. THE PATIENT IS REPORTEDLY DOING WELL. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276985 130 DEG LCP DHS PLATE-STANDARD BARREL 10 HOLES/188MM-STERILE PLATE, FIXATION, BONE HRS SYNTHES SELZACH 8249640

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention