BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INION CPS BIODEGRADABLE FIXATION SYSTEM

    MDR report key: 865232 · Received June 12, 2007

    Report

    Report Number
    9710629-2007-00002
    Event Type
    Malfunction
    Date Received
    June 12, 2007
    Date of Event
    May 2, 2007
    Report Date
    June 11, 2007
    Manufacturer
    INION OY
    Product Code
    MAI
    PMA / PMN Number
    K010351
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS IMPOSSIBLE TO KNOW WHAT HAS BEEN THE CAUSE OF THE EXPERIENCED PROBLEMS (FIXATION/MECHANICAL FAILURES, ANTICIPATED RISK) WITHOUT MORE DETAILED INFORMATION. FURTHER INFORMATION HAS BEEN REQUESTED IN THREE SEPARATE ATTEMPTS WITHOUT RESPONSE. AS THE SURGEON IS ASSUMED TO BE A NEW USER OF THE INION CPS SYSTEM, AND THERE IS A LEARNING CURVE WITH BIODEGRADABLE IMPLANTS, THE PROBLEMS ARE MOST LIKELY CAUSED BY IMPROPER USE. THIS ASSUMPTION IS SUPPORTED BY THE FACT THAT OTHER INVESTIGATORS OF THE SAME STUDY HAVE NOT REPORTED ANY PROBLEMS. PLEASE NOTE THE FOLLOWING STATEMENTS IN THE IFU: INCORRECT SELECTION, PLACEMENT, POSITIONING, AND FIXATION OF THE IMPLANT CAN CAUSE SUBSEQUENT UNDESIRABLE RESULTS. THE SURGEON SHOULD BE FAMILIAR WITH THE DEVICES, THE METHOD OF APPLICATION AND THE SURGICAL PROCEDURE PRIOR TO PERFORMING THE SURGERY. DO NOT USE FOR UNINTENDED APPLICATIONS! PROPER FUNCTION (I.E. EFFECTIVITY AND SAFETY) OF THESE IMPLANTS CAN NOT BE GUARANTEED IN CASE OF OFF-LABEL USE. THE PATIENT SHOULD BE WARNED THAT THE IMPLANTS CAN BREAK OR LOOSEN AS A RESULT OF EARLY STRESS, ACTIVITY OR LAD BEARING. COMPLICATIONS ARE SIMILAR TO THOSE WITH ANY METHOD OF INTERNAL FIXATION: PREMATURE BENDING, LOOSENING, BREAKAGE OR MIGRATION OF THE DEVICES MAY RESULT FROM EARLY STRESS, ACTIVITY OR LOAD BEARING.

    Description of Event or Problem · 1

    ACCORDING TO THE RECEIVED INFORMATION, A SURGEON PARTICIPATING IN AN INDEPENDENT CLINICAL STUDY WHERE THE INION CPS SYSTEM IS COMPARED TO METAL FIXATION HAS EXPERIENCED SOME PROBLEMS (MAXILLARY RELAPSE IN ONE PATIENT AND PLATE BREAKAGE IN ANOTHER CASE)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION CPS BIODEGRADABLE FIXATION SYSTEM BONE SCREW, BONE PLATE MAI INION OY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other