BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/10 HOLES/RIGHT

    MDR report key: 7193860 · Received January 16, 2018

    Report

    Report Number
    2939274-2018-50260
    Event Type
    Injury
    Date Received
    January 16, 2018
    Date of Event
    January 20, 2017
    Report Date
    December 20, 2017
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    PMA / PMN Number
    K120854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). ORIGINAL IMPLANT DATE IS UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY: PART NO.: 02.118.008, LOT NO.: 9151651. (B)(4). RELEASE TO WAREHOUSE DATE: 25.SEP.2014. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY REVIEW REVEALED NO COMPLAINT RELATED ANOMALIES OR NON-CONFORMANCE. BASED ON THE INFORMATION AVAILABLE, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF A 1 PLATE, 4 CORTEX SCREW. 4 VARIABLE ANGLE LOCKING COMPRESSION SCREW AND 1 METAPHYSEAL SCREW ON (B)(6) 2017 DUE TO RIGHT TIBIAL INFECTION. THE PLATE AND SCREWS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. THE DEVICES WERE REMOVED INTACT AND AN ANTIBIOTIC NAIL WAS IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS FINE. THE PATIENT MAY BE SCHEDULED FOR ADDITIONAL SURGERIES AS PART OF A STAGED RE-IMPLANTATION. THIS COMPLAINT IS FOR TEN (10) DEVICES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37485 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/10 HOLES/RIGHT PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH 02.118.008 9151651

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention