BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTPL 1.5 20HO SPACE4.5 TI

    MDR report key: 3221048 · Received July 11, 2013

    Report

    Report Number
    2520274-2013-04214
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 14, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K102656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE MEASURABLE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS WAS NOT POSSIBLE SINCE WE ARE NOT AWARE OF THE CONCERNED LOT NUMBER. THE INVESTIGATION OF THE COMPLAINED PLATES SHOW NO IRREGULARITIES. THE SURFACES OF THE CROSS-SECTIONS IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY AS WELL. UNFORTUNATELY THE INFORMATION GIVEN DID NOT PROVIDE SUFFICIENT EVIDENCE FOR AN EXACT DETERMINATION OF THE FAILURE REASON. WE ARE AWARE OF THE FACT THAT THE PLATE IS DELICATE, NEVERTHELESS WE SUPPOSE THAT A MECHANICAL OVERLOAD WELL BEYOND ITS CALCULATED DESIGN CAUSED THE BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    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 ON GOING; NO CONCLUSION COULD BE DRAWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THREE AND A HALF MONTHS AFTER THE SURGERY ON (B)(6) 2012, THE PATIENT COMPLAINED OF MAXILLARY MOBILITY. THE CLINICAL EVALUATION CONFIRMS MOBILITY UP TO 3 MM. THE SECOND INTERVENTION SHOWS THE FRACTURE OF AN ANTERIOR PLATE AND LOOSE SCREWS, WHICH WERE REMOVED AND CHANGED AND (B)(6) 2013. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320304 ADAPTPL 1.5 20HO SPACE4.5 TI JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR