BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA-LCP DORSAL DRP 2.4 RAD COLUMN 5HO L46

    MDR report key: 3200890 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-03923
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 10, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K102694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. DATE OF MANUFACTURE WAS DETERMINED FROM LOT NUMBER OBTAINED FROM DEVICE RECEIVED. COMPLAINT NUMBER SHOULD BE (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE EXAMINATION OF THE RAW-MATERIAL INSPECTION SHEETS AND THE MANUFACTURING DOCUMENTS SHOWED NO DEVIATIONS IN RELATION TO CHEMICAL COMPOSITION AND MECHANICAL PROPERTIES. THE CHEMICAL COMPOSITION AND THE MECHANICAL PROPERTIES ARE IN ACCORDANCE TO THE INTERNATIONAL STANDARDS. THE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING AND AO/ASIF SPECIFICATIONS. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, WE CAN CONCLUDE THAT THE IMPLANT WAS SUBJECTED TO MODERATE DYNAMIC BENDING LOADS AND PROBABLY TORSIONAL LOADS TOO. CONSTANTLY ALTERNATING LOADS LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE PLATE. THE PLATE COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD, RESPECTIVELY FATIGUE FAILURE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT IMPLANTED ON (B)(6) 2013 WITH PLATES AND SCREWS FOR DOUBLE WRIST FRACTURE, LEFT AND RIGHT. VA LCP DORSAL DISTAL RADIUS PLATES ARE BROKEN, WITHOUT AN ASSIGNABLE CAUSE. AFTER ALMOST 4 MONTHS THERE STILL WAS A NON UNION IN THE RIGHT RADIUS. BOTH PLATES WERE REMOVED (B)(6) 2013 AND REPLACED BY VA LCP VOLAR 2COLUMN PLATES, BECAUSE OF THE NON UNION. THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301625 VA-LCP DORSAL DRP 2.4 RAD COLUMN 5HO L46 HRS SYNTHES GMBH 8165554

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention