BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, RIB REPLACEMENT

    MDR report key: 4598922 · Received March 13, 2015

    Report

    Report Number
    2520274-2015-11426
    Event Type
    Injury
    Date Received
    March 13, 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. MAREDI (2014): EFFICACY AND SAFETY OF GROWING SPINAL SYSTEMS IN THE TREATMENT OF HYPERKYPHOSIS IN EARLY ONSET DEFORMITY. EUR SPINE J 23 (SUPPL 5) S500. ITALY. THIS REPORT IS FOR UNKNOWN VEPTR/UNKNOWN QUANTITY/UNKNOWN LOT. 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; MAREDI (2014): EFFICACY AND SAFETY OF GROWING SPINAL SYSTEMS IN THE TREATMENT OF HYPERKYPHOSIS IN EARLY ONSET DEFORMITY. EUR SPINE J 23 (SUPPL 5) S500. ITALY. THE AUTHORS RETROSPECTIVELY REVIEWED 18 PAEDIATRIC PATIENTS AFFECTED BY KYPHOTIC SPINAL DEFORMITY (T3-T12 KYPHOSIS >60) SURGICALLY TREATED WITH GROWING ROD OR VEPTR-LIKE SYSTEMS FROM 2007 TO 2014. THE ETIOLOGY:IDIOPATHIC (5), KYPHOSIS IN MORQUIO (1) AND IN POTT DISEASE (1), CONGENITAL SCOLIOSIS (4), TRISOMY 8 (1), ESCOBAR SYNDROME (1), PRADER WILLI (1), SPONDYLOCOSTAL DYSPLASIA (1), ARTHROGRYPOSIS (3). THERE WERE 9 MALES AND 9 FEMALES, WITH A MEAN AGE OF 7 YEARS. DUAL GROWING ROD WAS IMPLANTED IN 9 CASES, VEPTR IN 11 (ALWAYS RIB TO SPINE CONSTRUCT). PRE-OPERATIVE MAIN THORACIC SCOLIOSIS AVERAGED 67 DEGREES, LUMBAR SCOLIOSIS 55 DEGREES AND THORACIC KYPHOSIS 73 DEGREES, 67 DEGREES IN PATIENTS TREATED WITH GROWING ROD AND 77 DEGREES FOR THOSE TREATED WITH VEPTR. FOLLOW UP (RANGE 6 MONTHS TO 7 YEARS). AFTER FIRST SURGERY, THORACIC KYPHOSIS WAS CORRECTED FROM A MEAN VALUE OF 73 DEGREES TO 52 DEGREES; IN CASES TREATED WITH GROWING ROD, KYPHOSIS WAS CORRECTED FROM 67 DEGREES TO 44 DEGREES, IN CASES TREATED WITH VEPTR FROM 77 DEGREES TO 60 DEGREES. AT FINAL FOLLOW UP, AFTER 31 LENGTHENING PROCEDURES, A LOSS OF CORRECTION OCCURRED ON SAGITTAL PLANE:THORACIC KYPHOSIS INCREASED FROM 52 DEGREES TO 59 DEGREES; IN CASE OF GROWING ROD, FROM 44 DEGREES TO 50 DEGREES, IN CASE OF VEPTR FROM 58 DEGREES TO 68 DEGREES. THIS REPORT REFERS TO 15 MINOR COMPLICATIONS OCCURRED IN 7 PATIENTS, REQUIRING REVISION SURGERY IN 7. THIS IS REPORT 1 OF 1 FOR (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
    173388 PROSTHESIS, RIB REPLACEMENT MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention