BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM MATRIXRIB PRE-CONTOURED PL 16 HOLES FOR RIGHT RIBS 4 AND 5

    MDR report key: 3151576 · Received June 7, 2013

    Report

    Report Number
    2520274-2013-03206
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 10, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K081623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE EXACT DATE OF THE PROCEDURE IS UNKNOWN. REPORTEDLY THE PROCEDURE MAY HAVE TAKEN PLACE IN 2010. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT IMPLANTED WITH MATRIXRIB CONSTRUCT AFTER A CRUSH INJURY WITH NON-UNION ON AN UNKNOWN DATE IN (B)(6) 2010. DATE OF IMPLANT WAS REPORTED AS (B)(6) 2012. DATE OF EXPLANT WAS REPORTED AS (B)(6) 2012.

    Description of Event or Problem · 1

    WHILE WORKING ON A PRESENTATION WITH A SURGEON, ONE OF THE SLIDES NOTED A MATRIXRIB PLATE REMOVAL DUE TO AN INFECTION. THE DATE OF THE PROCEDURE IS UNKNOWN. REPORTEDLY THE PROCEDURE TOOK PLACE SOMETIME IN 2010. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR AN UNKNOWN MATRIXRIB PLATE. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 31 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253084 TITANIUM MATRIXRIB PRE-CONTOURED PL 16 HOLES FOR RIGHT RIBS 4 AND 5 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention