BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 7H HD/5H SHAFT/LT-STER

    MDR report key: 3904210 · Received July 1, 2014

    Report

    Report Number
    1000562954-2014-10097
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    May 31, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    PMA / PMN Number
    PK083694
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE PLATE WAS RECEIVED SLIGHTLY USED BUT OTHERWISE IN GOOD CONDITION. THE PLATE WAS EXAMINED AND WE CANNOT DETECT ANY ABNORMALITIES WHICH COULD HAVE CAUSED THE PROBLEM. THE PLATE IS GOOD AND SHOWS A SLIGHTLY USED CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD REVIEW FOR THE PLATE WAS CONDUCTED AND THERE WERE NO FINDINGS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. IT IS LIKELY THAT EITHER THE SCREW WAS NOT FULLY LOCKED INTO THE PLATE DURING SURGERY OR STRONG MOVEMENT BY THE PATIENT MAY HAVE CAUSED MOVEMENT OR LOOSENING OF THE SCREW. NO PRODUCT FAULT COULD BE DETECTED. 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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. 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. MEDWATCH SUBMITTED TO FDA ON 6/30/2014- ADVISED BY FDA ON 7/1/2014 TO RE-SUBMIT 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 EU PROVIDES INFORMATION FROM A FACILITY IN (B)(6) AS FOLLOWS: IN (B)(6) 2014, PATIENT COMPLAINED OF FOREIGN BODY SENSATION AT THE WRIST, PLATE AND SCREW IN QUESTION WERE IMPLANTED IN THE PATIENT FOR DISTAL RADIUS FRACTURE. IT WAS LATER CONFIRMED THAT THE SCREW AT THE MOST DISTAL HOLE OF THE PLATE LOOSENED AND SCREW HEAD BACKED OUT. THE PATIENT WAS FOLLOWED AFTERWARD SINCE BONE-UNION HAD NOT BEEN COMPLETED. ON (B)(6) 2014, REMOVAL OPERATION OF THE IMPLANTS WAS PERFORMED. BONE-UNION WAS CONFIRMED. NO FURTHER INFORMATION WAS NOTED. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382330 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 7H HD/5H SHAFT/LT-STER PLATE,FIXATION,BONE HRS SYNTHES MEZZOVICO 8251269

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention