BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PLATE

    MDR report key: 4231926 · Received November 6, 2014

    Report

    Report Number
    2520274-2014-14564
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 8, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: REPORTED AS; SUMMER 2014. THIS REPORT IS FOR TWO OF UNKNOWN RAPIDSORB SCREWS/UNKNOWN LOTS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE MANUFACTURING INVESTIGATION REPORTED TWO RAPIDSORB SCREWS RECEIVED WERE INTACT. SINCE THE ARTICLE AND LOT NUMBERS OF THE INVOLVED IMPLANTS ARE NOT KNOWN AND DUE TO THE LACK OF FURTHER CLINICAL INFORMATION THE PRESENT COMPLAINT CANNOT BE FULLY ANALYZED AND THE INVESTIGATION IS UNABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING A POSSIBLE FAILURE REASON. THE CORRESPONDING ¿INSTRUCTION FOR USE¿ (SM_706475) REFERS TO SOME POTENTIAL COMPLICATIONS AS FOLLOWS: IN GENERAL, GOOD TISSUE RECEPTIVITY BY IMPLANTATION OF RESORBABLE COPOLYMER POLY(L-LACTIDE-CO-GLYCOLIDE) IMPLANTS IN BONE IS SUPPORTED BY EXPERIMENTAL AND CLINICAL DATA. NEVERTHELESS, THE FOLLOWING COMPLICATIONS ARE POSSIBLE: NEUROVASCULAR INJURIES CAUSED BY SURGICAL TRAUMA FOREIGN BODY REACTIONS ALLERGIC REACTIONS INFLAMMATORY REACTIONS INFECTIONS CAN LEAD TO FAILURE OF THE PROCEDURE 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 THERE WAS PROBLEMS WITH WOUND CLOSER FOLLOWING SURGERY AT TWO INCISION POINTS. THE PLATE WAS DIRECTLY UNDER THE SCALP SUTURE. PER AN INTERNAL MEDICAL REVIEW BY THE MEDICAL DIRECTOR; NO ADDITIONAL INFORMATION IN REGARDS THIS CASE COULD BE PROVIDED. THERE WAS NO REPORT OF A SURGICAL DELAY. THIS REPORT IS FOR TWO OF UNKNOWN RAPIDSORB SCREWS. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714439 BONE PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention