BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, RIB REPLACEMENT

    MDR report key: 4605390 · Received March 16, 2015

    Report

    Report Number
    2520274-2015-11425
    Event Type
    Injury
    Date Received
    March 16, 2015
    Report Date
    February 24, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    MDI
    PMA / PMN Number
    PH030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. VENTURA: THE SAGITTAL BALANCE CHALLENGE IN FUSIONLESS SURGERY: PJK PREDICTING FACTORS IN (2014)VEPTR TECHNIQUE.EUR SPINE J, VOL 23 (SUPPL 5) S499. THIS REPORT IS FOR UNKNOWN VEPTR/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(4). 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 SUBSEQUENT REVIEW OF THE FOLLOWING ABSTRACT; VENTURA: THE SAGITTAL BALANCE CHALLENGE IN FUSIONLESS SURGERY: PJK PREDICTING FACTORS IN (2014)VEPTR TECHNIQUE.EUR SPINE J, VOL 23 (SUPPL 5) S499. SPAIN ARTICLE. CLINICAL AND RADIOGRAPHIC DATA OF 34 PATIENTS (MEAN AGE OF 6.75) FROM A SINGLE CENTER TREATED WITH VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) WERE RECORDED WITH A MINIMUM 2-YEAR FOLLOW-UP (MEAN 4.5 YEARS). ANCHORAGE LEVELS, PROXIMAL JUNCTIONAL KYPHOSIS, CORONAL AND SAGITTAL BALANCE, SPACE AVAILABLE FOR THE LUNG (SAFL) AND COMPLICATIONS WERE RECORDED BEFORE, DURING AND AFTER TREATMENT. THIRTY-FOUR PATIENTS WERE OPERATED FROM 2005 TO 2011 USING VEPTR (IDIOPATHIC: 6, NEURO-MUSCULAR: 13, CONGENITAL: 12, OTHERS: 6).THE INCIDENCE OF PJK WAS SEEN IN 12 PATIENTS (35 %). THE DEVELOPMENT OF PJK WAS ASSOCIATED WITH PREVIOUS KYPHOSIS T4¿T12 >40 DEGREES AND PROXIMAL END VERTEBRAL SELECTION FROM T5 OR DISTALLY. STATISTICAL DIFFERENCES WERE NOT FOUNDED IN NON-IDIOPATHIC PATIENTS, PRIOR LUMBAR LORDOSIS, SAFL OR COBB ANGLE AND FAILURE OF DISTAL SEGMENT SELECTION. ONLY 3 OF THE 12 PATIENTS THAT DEVELOPED PJK NEEDED ADDITIONAL SPECIFIC SURGERY TO TREAT THORACIC KYPHOSIS. OTHER COMPLICATIONS LIKE HARDWARE FAILURE OR PROGRESSIVE KYPHOSIS WERE RECORDED. THIS REPORT REFERS TO COMPLICATIONS; PROGRESSIVE JUNCTIONAL KYPHOSIS REPORTED POST-OPERATIVELY IN 12 PATIENTS OUT OF WHICH 3 NEEDED REVISION TO TREAT THORACIC KYPHOSIS. (B)(4). THIS REPORT IS FOR AN UNKNOWN VEPTR, UNKNOWN PART#/LOT# AND UNKNOWN QUANTITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177029 PROSTHESIS, RIB REPLACEMENT MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention