BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, RIB REPLACEMENTPROSTHESIS, RIB REPLACEMENT

    MDR report key: 4592233 · Received March 11, 2015

    Report

    Report Number
    2520274-2015-11708
    Event Type
    Injury
    Date Received
    March 11, 2015
    Report Date
    February 15, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    MDI
    PMA / PMN Number
    PH030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LITERATURE CITATION: CAMPBELL, R.M., ET AL (2007). THE EFFECT OF MID-THORACIC VEPTR OPENING WEDGE THORACOSTOMY ON CERVICAL TILT ASSOCIATED WITH CONGENITAL THORACIC SCOLIOSIS IN PATIENTS WITH THORACIC INSUFFICIENCY SYNDROME. SPINE, VOLUME 32, NUMBER 20, PP 2171-2177. USA ARTICLE. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF VEPTR WITH UNKNOWN PART AND LOT NUMBERS. (B)(6). 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: CAMPBELL, R.M., ET AL (2007). THE EFFECT OF MID-THORACIC VEPTR OPENING WEDGE THORACOSTOMY ON CERVICAL TILT ASSOCIATED WITH CONGENITAL THORACIC SCOLIOSIS IN PATIENTS WITH THORACIC INSUFFICIENCY SYNDROME. SPINE, VOLUME 32, NUMBER 20, PP 2171-2177. USA ARTICLE. THE PURPOSE OF THE STUDY WAS TO REPORT THE EFFICACY AND SAFETY OF VEPTR MI-THORACIC OPENING WEDGE THORACOSTOMY IN TREATMENT OF CERVICAL TILT AND HEAD/TRUNCAL DECOMPENSATION IN CHILDREN WITH THORACIC INSUFFICIENCY SYNDROME ASSOCIATED WITH THORACIC CONGENITAL SCOLIOSIS. THE STUDY INCLUDED: 14 PATIENTS (6 FEMALES, 8 MALES), MEAN AGE AT TIME OF SURGERY 4.4 YEARS (RANGING 1.8-12.5 YEARS), MEAN FOLLOW-UP TIME WAS 3.4 YEARS (RANGING 2-5.75 YEARS), AND THE PATIENTS HAD THE FOLLOWING CO-MORBIDITIES: CONGENITAL RENAL ABNORMALITIES, CONGENITAL HEART DISEASE, ASTHMA, AND SPINAL CORD ABNORMALITIES. TWO PATIENTS HAD SPINAL FUSIONS BEFORE VEPTR TREATMENT. FOUR PATIENTS HAD TETHER RELEASE BEFORE VEPTR. MOST PATIENTS HAD A UNILATERAL HYBRID RIB-TO SPINE VEPTR AND RIB-TO RIB VEPTR; 3 PATIENTS HAD BILATERAL VEPTR CONSTRUCT. MULTIPLE RADIOGRAPHS WERE TAKEN PRE-OPERATIVELY AND POST-OPERATIVELY AS WELL AS CT SCANS AND MRIS. COMPLICATIONS: A (B)(6) FEMALE HAD A SEVERE RIB FUSION WITH POST-OP PARTIAL BRACHIOPLEXOPATHY WITH WEAKNESS AND BURNING PAIN OF THE OPERATIVE UPPER EXTREMITY WITHIN A WEEK OF SURGERY. TWO WEEKS POST-OP, SHE HAD SURGICAL INTERVENTION AND RECOVERED. THIS REPORT IS FOR AN UNKNOWN VEPTR WITH UNKNOWN PART AND LOT NUMBERS AND QUANTITY. THIS IS REPORT 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166834 PROSTHESIS, RIB REPLACEMENTPROSTHESIS, RIB REPLACEMENT MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention