BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHYSPL 3.5 W/COAX-COMBIHO+2 DCP 6HO L

    MDR report key: 7114365 · Received December 13, 2017

    Report

    Report Number
    8030965-2017-50629
    Event Type
    Injury
    Date Received
    December 13, 2017
    Report Date
    November 15, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819810938
    PMA / PMN Number
    K042377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. DATE OF EVENT IS UNKNOWN. IMPLANT DATE IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. TELEPHONE NUMBER UNKNOWN. A DEVICE HISTORY RECORD REVIEW WAS REQUESTED. 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

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: 02.100.016, LOT NUMBER: 9897083, PART MANUFACTURE DATE: 15-SEP-2015, MANUFACTURING LOCATION: (B)(4), 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 PUBIC SYMPHYSIS PLATE 6 HOLES INCL 2 DCP 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. 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 FOLLOWS: IT WAS REPORTED ABOUT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) DISTAL FEMUR SURGERY, PERFORMED BY DR (B)(6) AT (B)(6) HOSPITAL ON (B)(6) 2017. REVISION OCCURRED ON (B)(6) 2017 FOR OPEN REDUCTION INTERNAL FIXATION OF OPEN BOOK PELVIS PERFORMED USING STANDARD TECHNIQUE BY SPECIALIST ORTHOPAEDIC TRAUMA SURGEON. INFECTION IS SUSPECTED SO IMPLANTS REMOVED FROM THE PUBIC SYMPHSIS. ONE SCREW BROKEN, THE REST WERE INTACT. PATIENT ACTIVITY LEVELS; WEIGHT BEARING. THIS COMPLAINT IS FOR THE INFECTION. (B)(4) IS FOR THE BROKEN SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894155 SYMPHYSPL 3.5 W/COAX-COMBIHO+2 DCP 6HO L PLATE,FIXATION,BONE HRS OBERDORF : SYNTHES PRODUKTIONS GMBH 9897083 07611819810938

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention