BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOW PROFILE RECONSTRUCTION PLATE 4 HOLES

    MDR report key: 9627941 · Received January 24, 2020

    Report

    Report Number
    8030965-2020-00609
    Event Type
    Injury
    Date Received
    January 24, 2020
    Date of Event
    January 1, 2019
    Report Date
    January 7, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819811911
    PMA / PMN Number
    K031573
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: KTT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 245.024, LOT NUMBER: H802396, PART MANUFACTURE DATE: 21-DEC-2018, MANUFACTURING LOCATION: (B)(4), PART EXPIRATION DATE: N/A, NONCONFORMANCE NOTED: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 3.5MM LOW PROFILE RECONSTRUCTION PLATE 4 HOLES PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NONCONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HARDWARE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO INFECTION. INITIAL IMPLANT DATE WAS (B)(6) 2019. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM LOW PROFILE RECONSTRUCTION PLATE 4 HOLES. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4). THIS COMPLAINT INVOLVES TOTAL 12 DEVICES, ADDITIONAL DEVICES ARE REPORTED UNDER LINKED COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92536 3.5MM LOW PROFILE RECONSTRUCTION PLATE 4 HOLES PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH H802396 07611819811911

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention