BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSITION-PIN 4.5 F/LCP TI

    MDR report key: 6296818 · Received February 2, 2017

    Report

    Report Number
    3000270450-2017-10029
    Event Type
    Injury
    Date Received
    February 2, 2017
    Report Date
    January 12, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 498.803.01S, LOT# 9232115. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: NOV 04, 2014, EXPIRY DATE: OCT 01, 2024. NON-STERILE PART# 498.803.01, LOT# 7808520. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: OCT 06, 2014. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT INITIAL SURGERY FOR FEMORAL SHAFT FRACTURE. ON (B)(6) 2017, PATIENT UNDERWENT REVISION SURGERY AND REMOVED ALL OF THE IMPLANTS DUE TO AN INFECTION OF (B)(6). IT WAS NOTED THAT THERE WERE SOME INDICATIONS OF AN INFECTION ON A SURFACE OF THE PROXIMAL PORTION. THE SURGEON INCISED AND THERE WERE ABSCESSES OVER THE ENTIRE LENGTH OF PLATE. THE SURGEON COMMENTED THAT THE BONE UNION IS INCOMPLETE YET BUT HE WILL WAIT AND TRY WITH CONSERVATIVE TREATMENTS. HE ALSO COMMENTED THAT THE CAUSE IS UNCLEAR, BUT THE PATIENT SUFFERED FROM CIRRHOSIS BEFORE AND HER IMMUNE SYSTEM IS WEAK SO THE FACTOR MAY HAVE LED TO THE INCIDENT. PATIENT OUTCOME WAS REPORTED AS THE PATIENT SUFFERS FROM WEIGHT BEARING ORTHOSIS. THIS REPORT IS FOR ONE (1) POSITION-PIN 4.5 F/LCP TI. THIS IS REPORT 14 OF 17 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81922 POSITION-PIN 4.5 F/LCP TI SCREW,FIXATION,BONE HWC SYNTHES SELZACH 9232115

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention