BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMMON NAME PROSTHESIS, RIB REPLACEMENT

    MDR report key: 3776263 · Received April 28, 2014

    Report

    Report Number
    2520274-2014-11052
    Event Type
    Injury
    Date Received
    April 28, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    MDI
    PMA / PMN Number
    PH030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CAN INFECTION ASSOCIATED WITH RIB DISTRACTION TECHNIQUES BE MANAGED WITHOUT IMPLANT REMOVAL? JOHN T. SMITH , MD , AND MELISSA S. SMITH , CPNP. LIPPINCOTT WILLIAMS & WILKINS SPINE VOLUME 36, NUMBER 25 (2011), PP 2176¿2179. THIS REPORT IS FOR UNKNOWN VEPTR CONSTRUCT. 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. CAN INFECTION ASSOCIATED WITH RIB DISTRACTION TECHNIQUES BE MANAGED WITHOUT IMPLANT REMOVAL? JOHN T. SMITH , MD , AND MELISSA S. SMITH , CPNP. LIPPINCOTT WILLIAMS & WILKINS SPINE VOLUME 36, NUMBER 25 (2011), PP 2176¿2179. THIS IS AN INSTITUTIONAL REVIEW BOARD¿APPROVED RETROSPECTIVE REVIEW OF MEDICAL RECORDS OF ALL PATIENTS WHO HAD VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) PROCEDURES AND DEVELOPED INFECTIONS AT PRIMARY CHILDREN¿S MEDICAL CENTER (PCMC) FROM 2002 TO 2008. NINETY-SEVEN PATIENTS UNDERWENT 678 VEPTR PROCEDURES. NINETEEN INFECTIONS DEVELOPED IN 16 PATIENTS, WITH A 2 PERCENT OVERALL RATE OF INFECTION PER PROCEDURE. THE AVERAGE BODY MASS INDEX (16.2) AND ABSOLUTE NEUTROPHIL COUNT (8.2) WERE PREDICTABLY LOW FOR THIS POPULATION. THE DIAGNOSIS WAS VARIED. INFECTION WAS ASSOCIATED WITH INITIAL IMPLANTATION (31 PERCENT), EXPANSION (47 PERCENT), EXCHANGE (5 PERCENT), AND REVISION (21 PERCENT). SEVENTEEN OF 19 INFECTIONS FOLLOWED A WOUND DEHISCENCE. THIRTEEN INFECTIONS WERE CLASSIFIED AS SUPERFICIAL AND SIX DEEP. ALL PATIENTS WERE TREATED WITH INITIAL IRRIGATION AND DEBRIDEMENT (I AND D) AND INTRAVENOUS ANTIBIOTICS. THE AVERAGE DURATION OF INTRAVENOUS THERAPY WAS 58 DAYS, FOLLOWED BY ORAL SUPPRESSIVE THERAPY FOR 34 DAYS (2¿126). THREE PATIENTS REQUIRED MORE THAN ONE DEBRIDEMENT TO CONTROL THE INFECTION (RANGE, 2¿4 I AND D). NO PATIENT HAS REQUIRED VEPTR REMOVAL TO RESOLVE THE INFECTION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4), FOR INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254616 COMMON NAME PROSTHESIS, RIB REPLACEMENT MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention