BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM TI MATRIXRIB STRAIGHT PL 24 HOLES/240MM LENGTH

    MDR report key: 4124543 · Received September 29, 2014

    Report

    Report Number
    1000562954-2014-10185
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    August 13, 2014
    Report Date
    September 3, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    PMA / PMN Number
    PK133616
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NON CONFORMANCE REPORT (NCR) 3202943 WAS GENERATED DURING INSPECTION CONTROL STEP AFTER ANODIZATION PROCESS DUE TO COSMETIC ISSUE, 3 PARTS HAD SOME DENTS ON THE SURFACE. THE 3 PARTS WERE SCRAPPED. THIS NON-CONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION SINCE THE DENTS ON THE SURFACE HAVE NO RELATIONSHIP TO THE PERFORMANCE OF THE BENDING PLIERS. REVIEW OF THE DHR SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PECTUS REPAIR PROCEDURE THE SURGEON WAS NOT SATISFIED WITH THE BEND THAT WAS ACHIEVED ON THE PLATE USING THE BENDING PLIERS. THE SURGEON FELT THE PLIERS PRODUCED A TORSIONAL BEND TO THE PLATE, WHICH WAS NOT WANTED. THE SURGEON HAS REPORTED THAT THE POST-OPERATIVE RESULT OF THE PECTUS REPAIR WAS EXCELLENT WITH NO HARM TO THE PATIENT. THE SURGEON AND PATIENT ARE REPORTED TO BE VERY HAPPY WITH THE RESULTS. THE EVENT PROLONGED THE SURGERY APPROXIMATELY 60 MINUTES. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606013 1.5MM TI MATRIXRIB STRAIGHT PL 24 HOLES/240MM LENGTH PLATE, FIXATION, BONE HRS SYNTHES MEZZOVICO 8517583

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention