BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION CPS BIODEGRADABLE FIXATION SYSTEM

    MDR report key: 2202145 · Received August 3, 2011

    Report

    Report Number
    9710629-2011-00007
    Event Type
    Injury
    Date Received
    August 3, 2011
    Report Date
    August 2, 2011
    Manufacturer
    INION OY
    Product Code
    JEY
    PMA / PMN Number
    K010352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF PUBLISHED DATA AND OCCURRENCE RATE. CONCLUSION: ANTICIPATED ADVERSE EVENT. ACCORDING TO THE PUBLICATION OF TURVEY, THE SUCCESS RATE OF THE INION CPS SYSTEM WAS 94% IN 575 OPERATIONS PERFORMED DURING THE PAST 10 YEARS. IN 6% OF CASES ADDITIONAL OPERATION ROOM TIME WAS REQUIRED DUE TO SCREW BREAKAGE (IN 11 PATIENTS, I.E., 2%) OR POSTOPERATIVE INFLAMMATION (IN 23 PATIENTS, I.E., 4%). THESE RESULTS WERE IDENTICAL WITH THE RESULTS OF THE BIODEGRADEABLE BIONX SYSTEM (SYSTEM RATE 94%, BREAKAGE 1%, INFLAMMATION 5%). BOTH BIODEGRADEABLE SYSTEMS HAD LOWER COMPLICATION RATES THAN CONVENTIONAL TITANIUM IMPLANTS (10% ACCORDING TO TURVEY). AS CONCLUDED BY THE AUTHOR; PLLDL 70/30 BONE PLATES AND SCREWS MAY BE USED SUCCESSFULLY IN A VARIETY OF CRANIOMAXILLOFACIAL SURGICAL APPLICATIONS. THE ADVANTAGES INCLUDE THE GRADUAL TRANSFERENCE OF PHYSIOLOGICAL FORCES TO THE HEALING BONE, THE REDUCED NEED FOR A SECOND OPERATION TO REMOVE THE MATERIAL AND ITS POTENTIAL TO SERVE AS A VEHICLE TO DELIVER BONE-HEALING PROTEINS TO FRACTURE/OSTEOTOMY SITES. BONE HEALING WAS NOTED AT ALL SITES, EVEN WHERE EXUBERANT INFLAMMATION REQUIRED A SECOND SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    ACCORDING TO A PUBLISHED STUDY (TURVEY ET AL., BIODEGRADABLE FIXATION FOR CRANIOMAXILLOFACIAL SURGERY: A 10-YEAR EXPERIENCE INVOLVING 761 OPERATIONS AND 745 PATIENTS", INT. J. ORAL MAXILLOFAC. SURG. 2011: THE 10-YEAR STUDY INCLUDED MORE THAN 1400 SURGICAL PROCEDURES (ORTHOGNATHIC SURGERY 685, BONE GRAFT RECONSTRUCTION 37, TRAUMA 191, AND TRANSCRANIAL SURGERY 20). THE SUCCESS RATE (NO BREAKAGE OR INFLAMMATION REQUIRING ADDITIONAL OPERATION ROOM TIME) WAS 94%. FAILURES OCCURRED BECAUSE OF SCREW BREAKAGE (14) OR EXUBERANT INFLAMMATION (31). FAILURE WAS DEFINED AS MATERIAL BREAKAGE OR AN ACUTE INFLAMMATORY RESPONSE DURING THE BIODEGRADATION PHASE, TO THE EXTENT THAT ANOTHER OPERATING ROOM PROCEDURE WAS NECESSARY FOR RESTABILISATION OR FOR DEBRIDEMENT. LOW GRADE, WELL-CONTROLLED DEGRADATION WITH A DRAINING INTRAORAL FISTULA WHICH WAS SELFLIMITING AND DID NOT REQUIRE AN OPERATING ROOM PROCEDURE WAS NOT CONSIDERED FAILURE. BREAKAGE RATE OF INION PRODUCTS WAS 2% AND THE INFLAMMATION RATE WAS 4%. FOR BIONX, IT WAS 1% AND 5% RESPECTIVELY. THE DIFFERENCE WAS NON-SIGNIFICANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention