BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, RIB REPLACEMENT

    MDR report key: 5956914 · Received September 16, 2016

    Report

    Report Number
    2520274-2016-14525
    Event Type
    Injury
    Date Received
    September 16, 2016
    Report Date
    July 27, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    MDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. SPONSELLER, P; ET AL (2016) SURGICAL TREATMENT OF PROGRESSIVE IDIOPATHIC EARLY-ONSET SCOLIOSIS: A COMPARISON OF GROWING RODS VERSUS VEPTR. AMERICAN ASSOC ORTHO SURGEONS. MARCH, PAPER NO. 101. THIS REPORT IS FOR AN UNKNOWN VEPTR (UNKNOWN QUANTITY/UNKNOWN LOT). (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING ABSTRACT: SPONSELLER, P; ET AL (2016) SURGICAL TREATMENT OF PROGRESSIVE IDIOPATHIC EARLY-ONSET SCOLIOSIS: A COMPARISON OF GROWING RODS VERSUS VEPTR. AMERICAN ASSOC ORTHO SURGEONS. MARCH, PAPER NO. 101. THIS STUDY WAS TO COMPARE CLINICAL AND RADIOGRAPHIC RESULTS BETWEEN TWO FORMS OF DISTRACTION FOR IDIOPATHIC EARLY-ONSET SCOLIOSIS (IEOS): GROWING RODS (GR) AND VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) TO ALLOW SPINAL GROWTH WHILE PREVENTING CURVE PROGRESSION UNTIL SKELETAL MATURITY. TWO MULTICENTER EOS DATABASES WERE STUDIED TO IDENTIFY GR AND VEPTR PATIENTS WHO HAD IDIOPATHIC ETIOLOGIES WITH MINIMUM FIVE-YEAR FOLLOW UP AND GREATER THAN 4 LENGTHENINGS. STUDY TIME POINTS INCLUDED PREOPERATIVE, IMMEDIATE POSTOPERATIVE, AND MOST RECENT VISIT PRIOR TO FINAL TREATMENT. FIFTY GR AND 22 VEPTR PATIENTS MET INCLUSION CRITERIA. MEAN AGE AT SURGERY WAS SIMILAR (5.5 YRS GR VS. 4.3YRS VEPTR), AS WAS PREOPERATIVE MAIN CURVE, KYPHOSIS, SPINAL AND THORACIC HEIGHT. THE NUMBER OF LEVELS SPANNED BY CONSTRUCT WAS SIMILAR (11.5 TGR VS. 12.1 VEPTR); A UNILATERAL CONSTRUCT WAS PRESENT IN 50% (11/22) OF THE VEPTR AND 30% (15/50) OF THE GR PATIENTS. IMMEDIATELY POST IMPLANTATION THE GR PATIENTS HAD SIGNIFICANTLY GREATER CURVE CORRECTION, WHILE KYPHOSIS AND HEIGHT MEASUREMENTS WERE SIMILAR. POST-OPERATIVE FOLLOW UP WAS SIMILAR (8.3YRS GR VS.7.7YRS VEPTR); AS WELL AS NUMBER OF LENGTHENINGS (8.5GR VS. 9.8VEPTR). THE NUMBER OF PATIENTS WITH AT LEAST ONE COMPLICATION WAS SIMILAR (66.0% GR VS. 81.8% VEPTR). THERE WERE SIGNIFICANTLY MORE VEPTR PATIENTS WITH WOUND RELATED COMPLICATIONS (14.0% GR VS. 40.9% VEPTR). AT MOST RECENT FOLLOW UP, GR PATIENTS HAD SIGNIFICANT % GAIN THORACIC HEIGHT, LESS KYPHOSIS, AND A SIGNIFICANTLY LOWER INCIDENCE OF WOUND RELATED COMPLICATIONS. THIS REPORT IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN VEPTR AND REFERS TO THE SERIOUS INJURY OF UNKNOWN PATIENTS WHO EXPERIENCED WOUND RELATED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607100 PROSTHESIS, RIB REPLACEMENT MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention