BEUDAMED
    FDA Adverse Event Other Summary report: N

    HAND PLATING SYSTEM 1.6MM T PLATE

    MDR report key: 1760787 · Received July 9, 2010

    Report

    Report Number
    2027754-2010-00007
    Event Type
    Other
    Date Received
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    OSTEOMED LP
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN X RAY WAS PROVIDED THAT SHOWED THE SCREWS WERE STILL IN THE ORIGINAL PLATE. THE PLATE WILL NOT BE RETURNED TO THE COMPANY. THE PLATE WAS KEPT BY THE HOSPITAL'S LAB. ACCORDING TO THE DOCTOR, THE PATIENT WAS NONCOMPLIANT. DR. HAS NO OTHER QUESTIONS OR CONCERNS. NO LOT NUMBER INFORMATION WAS PROVIDED. THERE ARE NO SIMILAR REPORTS IN THE COMPANY DATABASE FOR THIS PART NUMBER. THE INSTRUCTIONS (IFU) WARN AGAINST USE IN PATIENTS WHO WOULD IGNORE POST-OPERATIVE INSTRUCTIONS AND LIMITATIONS OF INTERNAL RIGID FIXATION. PATIENTS MUST CLOSELY FOLLOW THE POST OPERATIVE INSTRUCTIONS FROM THEIR SURGEON. THE IFU ALSO WARNS THAT USE OF UNDERSIZED IMPLANTS IN ARES OF HIGH FUNCTIONAL STRESS MAY LEAD TO IMPLANT FRACTURE AND FAILURE.

    Description of Event or Problem · 1

    PATIENT RECEIVED A 1.6MM T PLATE ON (B)(6) 2010. THE DEVICE WAS EXPLANTED ON (B)(6) 2010, BECAUSE THE PLATE HAD FRACTURED. DOCTOR REPLACED DEVICE WITH A 2.0MM T PLATE. AN X RAY WAS PROVIDED THAT SHOWED THE SCREWS WERE STILL IN THE ORIGINAL PLATE. THE PLATE WILL NOT BE RETURNED TO THE COMPANY. THE PLATE WAS KEPT BY THE HOSPITAL'S LAB. ACCORDING TO THE DOCTOR, THE PATIENT WAS NONCOMPLIANT. DR. HAS NO OTHER QUESTIONS OR CONCERNS. NO LOT NUMBER INFORMATION WAS PROVIDED. THERE ARE NO SIMILAR REPORTS IN THE COMPANY DATABASE FOR THIS NUMBER. THE INSTRUCTIONS (IFU) WARN AGAINST USE IN PATIENTS WHO WOULD IGNORE POST-OPERATIVE INSTRUCTIONS AND LIMITATIONS OF INTERNAL RIGID FIXATION. PATIENTS MUST CLOSELY FOLLOW THE POST OPERATIVE INSTRUCTIONS FROM THEIR SURGEON. THE IFU ALSO WARNS THAT USE OF UNDERSIZED IMPLANTS IN AREAS OF HIGH FUNCTIONAL STRESS MAY LEAD TO IMPLANT FRACTURE AND FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAND PLATING SYSTEM 1.6MM T PLATE T PLATE HRS OSTEOMED LP 333-160X UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention