BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI CORTEX SCREW 18MM

    MDR report key: 4043145 · Received August 27, 2014

    Report

    Report Number
    9612488-2014-10351
    Event Type
    Injury
    Date Received
    August 27, 2014
    Report Date
    August 1, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HRS
    PMA / PMN Number
    PK131186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. ADDITIONAL PRODUCT CODE: HWC. IMPLANT DATE: UNKNOWN. EXPLANT DATE: UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NON-CONFORMANCE REPORTS 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. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WHO HAD BEEN IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) DISTAL FIBULA PLATE PRESENTED WITH A SKIN NECROSIS. THE PLATE WAS REMOVED EARLIER THAN INITIALLY PLANNED, AND THE NECROSIS HEALED. THE SURGEON DID NOT REPORT ANY PRODUCT DEFECTS FOR THE LCP DISTAL FIBULA PLATE, CANNULATED CANCELLOUS SCREW, K WIRE OR WINDING WIRE THAT WERE USED IN THIS SURGERY. THIS IS REPORT 2 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519707 3.5MM TI CORTEX SCREW 18MM PLATE, FIXATION, BONE HRS SYNTHES BETTLACH 3012927

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention