BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIB BLADE

    MDR report key: 5644428 · Received May 10, 2016

    Report

    Report Number
    2520274-2016-12620
    Event Type
    Injury
    Date Received
    May 10, 2016
    Date of Event
    April 20, 2016
    Report Date
    April 20, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    GAD
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND WEIGHT ARE UNKNOWN. OTHER): PARTIAL UDI NUMBER: (B)(4)LOT UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) II PROCEDURE ON (B)(6) 2016. WHILE ATTEMPTING TO MAINTAIN DISTRACTION OF THE RIBS POST-THORACOSTOMY, ONE FOOT FROM THE RIB BLADE DISENGAGED FROM THE RIB DISTRACTOR/RETRACTOR AND ENTERED THE CHEST CAVITY OF THE PATIENT. IT WAS VERY DIFFICULT FOR THE SURGEON TO RETRIEVE THE DEVICE AS IT HAD GONE VERY DEEP BENEATH THE LUNG. AFTER SEVERAL ATTEMPTS WITH DIFFERENT SIZED CLAMPS, THE FOOT OF THE DEVICE WAS ABLE TO BE EXTRACTED FROM THE PATIENT. THE PROCEDURE WAS ULTIMATELY COMPLETED, BUT A THIRTY (30) MINUTE PROLONGATION WAS NOTED. THE PATIENT WAS REPORTEDLY DOING WELL POST-OPERATIVE, BUT REQUIRED POST-OPERATIVE FOLLOW-UP OBSERVATION TO CHECK FOR PNEUMOTHORAX. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298702 RIB BLADE RETRACTOR GAD SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention