BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, RIB REPLACEMENT

    MDR report key: 3760366 · Received April 20, 2014

    Report

    Report Number
    2520274-2014-10905
    Event Type
    Injury
    Date Received
    April 20, 2014
    Report Date
    April 10, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    MDI
    PMA / PMN Number
    PH030009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FOR TREATMENT, NOT DIAGNOSIS. ¿VEPTR GROWING RODS FOR EARLY-ONSET NEUROMUSCULAR SCOLIOSIS.¿ DAINES, B.K., MD, FROST, N., MD, SONG, K.M., MD, WHITE, K.K., MD (2011, JANUARY, 7). CLINICAL ORTHOPAEDIC RELATED RESEARCH, 469, 1335-1341. THIS REPORT IS FOR AN UNKNOWN VEPTR CONSTRUCT/UNKNOWN LOT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 ¿VEPTR GROWING RODS FOR EARLY-ONSET NEUROMUSCULAR SCOLIOSIS.¿ DAINES, B.K., MD, FROST, N., MD, SONG, K.M., MD, WHITE, K.K., MD (2011, JANUARY, 7). CLINICAL ORTHOPAEDIC RELATED RESEARCH, 469, 1335-1341. FIFTY PATIENTS WERE TREATED WITH THE VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR; SYNTHES (B)(4)) CONSTRUCTS FOR THORACIC INSUFFICIENCY SYNDROME BETWEEN 2001 AND 2007. A 73 MONTH OLD FEMALE WITH NEUROMUSCULAR SCOLIOSIS UNDERWENT IMPLANTATION OF VEPTR FOR THE TREATMENT OF RIB FRACTURES. SUBSEQUENTLY, THE RODS FRACTURED AT THE THIRD EXPANSION; AND SUBSEQUENT ROD FRACTURE AFTER FIFTH EXPANSION. IT WAS CONCLUDED THAT THIS STUDY SUGGESTS GROWING CONSTRUCTS USING VEPTRTM CAN BE USED WITH RELATIVELY FEW COMPLICATIONS AND EXTENDS THE POTENTIAL USES OF THIS INSTRUMENTATION SYSTEM. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN VEPTR CONSTRUCT. THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239184 PROSTHESIS, RIB REPLACEMENT MDI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 73 MO Required Intervention