BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, RIB REPLACEMENT

    MDR report key: 4586774 · Received March 10, 2015

    Report

    Report Number
    2520274-2015-11574
    Event Type
    Injury
    Date Received
    March 10, 2015
    Report Date
    February 15, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    MDI
    PMA / PMN Number
    PH030009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LITERATURE CITATION: WALDHAUSEN, J.H.T., REDDING, G.J., AND SONG, K.M. (2007). VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB FOR THORACIC INSUFFICIENCY SYNDROME ¿ A NEW METHOD TO TREAT AN OLD PROBLEM. JOURNAL OF PEDIATRIC SURGERY VOL 42, P76-80. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF VEPTR WITH UNKNOWN PART AND LOT NUMBER. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: WALDHAUSEN, J.H.T., REDDING, G.J., AND SONG, K.M. (2007). VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB FOR THORACIC INSUFFICIENCY SYNDROME ¿ A NEW METHOD TO TREAT AN OLD PROBLEM. JOURNAL OF PEDIATRIC SURGERY VOL 42, P76-80. USA ARTICLE. THIS WAS RETROSPECTIVE REVIEW OF PERFORMED BETWEEN OCTOBER 2001 AND DECEMBER 2005. THE STUDY POPULATION INCLUDED: 22 PATIENTS, 36 VEPTR DEVICES, MOST HAD UNDERGONE SEQUENTIAL VEPTR EXPANSIONS, AGE RANGE 1 YEAR AND 8 MONTHS ¿ 15 YEARS AND 3 MONTHS. TWENTY SEVEN DEVICES WERE HYBRID AND 9 WERE RADIAL CONSTRUCTS. PATIENTS HAD BETWEEN 1-3 VEPTR DEVICES PLACED. THIS IS REPORT 2 OF 2 FOR (B)(4) FOR THE FOLLOWING EVENTS: VEPTR EROSION THROUGH BONE OR DISLODGMENT (N=7) WHICH REQUIRED REVISION SURGERY (MOST AT THE SUPERIOR CRADLE OF HYBRID DEVICE; 3 PATIENTS HAD IMPLANTS REMOVED). OUTGROWN (N=5) AND WERE REPLACED OR REMOVED. SOFT TISSUE EROSION/ESCHAR (N=1) CAUSING SUPERFICIAL INFECTION THAT WAS DEBRIDED AND RESOLVED WITH A REVISION. THIS REPORT IS FOR AN UNKNOWN VEPTR WITH AN UNKNOWN PART NUMBER, LOT NUMBER AND QUANTITY. THIS REPORT IS FOR 2 DEVICE(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165340 PROSTHESIS, RIB REPLACEMENT MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention