BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMMON NAME PROSTHESIS, RIB REPLACEMENT

    MDR report key: 3771183 · Received April 24, 2014

    Report

    Report Number
    2520274-2014-11042
    Event Type
    Injury
    Date Received
    April 24, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    MDI
    PMA / PMN Number
    PH030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE. PROXIMAL JUNCTIONAL KYPHOSIS AFTER VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB INSERTION. YING LI, MD, MERYL GOLD, BA, LAWRENCE KARLIN, MD. SPINE DEFORMITY 1 (2013) 425-433. THE LITERATURE ARTICLE IS ATTACHED TO THE COMPLAINT. THIS IS A RETROSPECTIVE REVIEW OF PATIENTS WHO HAD UNDERGONE VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) TREATMENT AT A SINGLE INSTITUTION. A TOTAL OF 68 PATIENTS UNDERWENT VEPTR TREATMENT BETWEEN 1999 AND 2009. DIAGNOSIS, AGE AT TIME OF VEPTR INSERTION, LOCATION OF VEPTR ANCHORS, PREOPERATIVE AND POSTOPERATIVE SCOLIOSIS, T2-T12 KYPHOSIS AND PROXIMAL JUNCTIONAL KYPHOSIS (PJK), TIME FROM VEPTR INSERTION TO DEVELOPMENT OF PJK, REVISION PROCEDURE FOR SIGNIFICANT PJK, CHANGE IN PJK AFTER THE REVISION PROCEDURE, AND PJK AT FINAL FOLLOW-UP WERE RECORDED. FOUR PATIENTS DEVELOPED PJK (6 PERCENT). ONE PATIENT HAD CONGENITAL SCOLIOSIS WITH RIB FUSIONS, 1 HAD SCOLIOSIS ASSOCIATED WITH A SYNDROME (ARTHROGRYPOSIS), AND 2 HAD NEUROMUSCULAR SCOLIOSIS (CORE MYOPATHY AND SPINAL CORD TUMOR). MEAN FOLLOW-UP WAS 5.7 YEARS. ALL PATIENTS DEVELOPED PJK WITHIN THE FIRST YEAR AFTER VEPTR INSERTION. TWO PATIENTS UNDERWENT REVISION TO GROWING RODS. ONE OF THESE PATIENTS HAD PREOPERATIVE HALO-GRAVITY TRACTION. MEAN PJK IN THESE 2 PATIENTS IMPROVED AFTER REVISION AND REMAINED STABLE AT AN AVERAGE FOLLOW-UP OF 2.9 YEARS. THIS REPORT IS FOR UNKNOWN VEPTR CONSTRUCT. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4). FOR (B)(6) PATIENT DEVELOPED PJK (PATIENT # (B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250037 COMMON NAME PROSTHESIS, RIB REPLACEMENT MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention