BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 6835821 · Received August 31, 2017

    Report

    Report Number
    2520274-2017-12202
    Event Type
    Injury
    Date Received
    August 31, 2017
    Report Date
    August 10, 2017
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN PLATE. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. PARTIAL PART NUMBER REPORTED IS 222.2XXS. LOT NUMBER REPORTED, 9840398, IS NOT A VALID LOT NUMBER FOR ANY PART BEGINNING WITH 222.2XX. DATE OF IMPLANT AND EXPLANT IS NOT KNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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.

    Additional Manufacturer Narrative · 1

    PATIENT GENDER REPORTED. PLATE FAILURE EVENT DATE REPORTED AS (B)(6) 2017. UPDATED COMPLAINT INFORMATION. PATIENT REPORTED PAIN & IMPOTENCE AT THE RIGHT KNEE CLIMBING THE STAIRS. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED AN UNKNOWN PLATE BROKE POST-OPERATIVE. A REVISION SURGERY WAS NECESSARY. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) UNKNOWN PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE: 22.SEP.17 UPDATE RECEIVED: PLATE FAILURE ON (B)(6) 2017. THE PATIENT REPORTED PAIN AND IMPOTENCE AT THE RIGHT KNEE CLIMBING THE STAIRS ON THIS DATE. PREVIOUS SURGERY ON (B)(6) 2016. THE PLATE FIXATION WAS PERFORMED FOR RIGHT FEMORAL FRACTURE ON IRRADIATED BONE IN A PATIENT FOLLOWING SARCOMA EXCISION AT THE RIGHT THIGH IN 1990. IT WAS REPORTED THAT A PLATE BROKE POST-OP AT AN SCREW HOLE A REVISION WAS NECESSARY. REMOVAL OF BROKEN PLATE AND REVISION WITH MEGAPROSTHESIS ON (B)(6) 2017. THE REVISION WAS SUCCESSFULLY. THIS COMPLAINT INVOLVES 1 PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614849 PLATE,FIXATION,BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention