BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-06444

    MDR report key: 3355258 · Received September 18, 2013

    Report

    Report Number
    2520274-2013-06444
    Event Type
    Injury
    Date Received
    September 18, 2013
    Report Date
    August 15, 2013
    Manufacturer
    SYNTHES
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: CHINESE JOURNAL OF SURGERY (OCT 2012); 50(10): 883-8. 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.

    Description of Event or Problem · 1

    JOURNAL ARTICLE RECEIVED: EARLY OUTCOME OF VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB TECHNIQUE IN TREATING EARLY-ONSET SCOLIOSIS; QIU Y, SUN X, WANG B, DING Q, ZHU ZZ, QIAN BP, YU Y, ZHU F, MA WW; CHINESE JOURNAL OF SURGERY (OCT 2012); 50(10): 883-8; REPORTED: INVESTIGATION OF VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) TECHNIQUE TO TREAT EARLY-ONSET SCOLIOSIS IN 11 PATIENTS. AGE RANGE AT INITIAL SURGERY WAS FROM 3.1 TO 9.8 YEARS. EXPANSION SURGERIES WERE SCHEDULED DURING REGULAR POST-OPERATIVE FOLLOW-UPS AT SIX TO TWELVE MONTH INTERVALS. SIX PATIENTS EXPERIENCED EIGHT COMPLICATIONS WHICH INCLUDED: RIB CRADLE DISLODGEMENTS, DISPLAYED INFECTION, INTRAOPERATIVE PLEURA RUPTURE AND LOOSENING OF LUMBAR PEDICLE SCREWS. THE AUTHORS CONCLUDED THE VEPTR TECHNIQUE WAS EFFECTIVE IN ALLOWING GROWTH OF SPINE AND CHEST WHILE PREVENTING CURVE PROGRESSION. THEY REPORTED THE COMPLICATION RATE WAS RELATIVELY HIGH FOR THE VEPTR TECHNIQUE AND THAT INDICATIONS FOR THE TECHNIQUE NEED TO BE STRICTLY SELECTED. PRODUCTS REPORTED ARE SYNTHES DEVICES. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR AN UNKNOWN LUMBAR PEDICLE SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470147 HWC SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention