BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, RIB REPLACEMENT

    MDR report key: 4599039 · Received March 13, 2015

    Report

    Report Number
    2520274-2015-11424
    Event Type
    Injury
    Date Received
    March 13, 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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. VENTURA: SPINAL STABILIZATION IN INTERMEDIATED SPINAL ATROPHY PATIENTS (SMA). A REVIEW OF 46 LIVING CASES. (ABSTRACTS FROM THE 3RD INTERNATIONAL CONGRESS ON EARLY ONSET SCOLIOSIS AND GROWING SPINE, 20¿21 NOVEMBER 2009, ISTANBUL, TURKEY), PG 530. THIS REPORT IS FOR UNKNOWN VEPTR/UNKNOWN QUANTITY/UNKNOWN LOT. (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 ABSTRACT: VENTURA: SPINAL STABILIZATION IN INTERMEDIATED SPINAL ATROPHY PATIENTS (SMA). A REVIEW OF 46 LIVING CASES. (ABSTRACTS FROM THE 3RD INTERNATIONAL CONGRESS ON EARLY ONSET SCOLIOSIS AND GROWING SPINE, 20¿21 NOVEMBER 2009, ISTANBUL, TURKEY), PG 530. THIS RETROSPECTIVE REVIEW INCLUDED 43 LIVING PATIENTS WITH SPINAL MUSCULAR ATROPHY (SMA) HAVING UNDERGONE SURGICAL CORRECTION OF THEIR SPINAL DEFORMITY BETWEEN 1990 AND 2008. TWO GROUPS WERE DISTINGUISHED WITH RESPECT TO THE TECHNIQUE OF SURGICAL INTERVENTION. GROUP I, 30 PATIENTS UNDERWENT POSTERIOR FUSION T.3 TO THE PELVIS OR TO L.5, AVERAGE FOLLOW UP 9 YEARS (2¿18). GROUP II, 16 PATIENTS TREATED WITH FUSIONLESS SURGICAL TECHNIQUES (10 GROWING RODS, 6 VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) AVERAGE FOLLOW UP 3 YEARS (2¿8). GROUP I, MEAN AGE 11 YEARS, OPERATIVE TIME 5 H, 3.7 UNITS OF BLOOD, 3 AVERAGE ICU STAY, 16 AVERAGE HOSPITAL STAY. MEAN PREOPERATIVE RADIOGRAPH: THORACOLUMBAR CURVES 838 (658¿1518), 60% CORRECTION; LUMBAR 808 (508¿1058), 52% CORRECTION; THORACIC 528 (408¿938), 47% CORRECTION. PELVIC OBLIQUITY 258 (18¿448) 71% CORRECTION. TWENTY-FOUR PATIENTS HAD FIXATION TO THE PELVIS (GALVESTON/ ILIAC SCREW), 6 CASES HAD FIXATION TO L.5. GROUP II, MEAN AGE 7 YEARS, OPERATIVE TIME 2.5 H, 0.7 UNITS OF BLOOD, 1 AVERAGE ICU DAY STAY AND 9 AVERAGE HOSPITAL STAY. MEAN PRE-OPERATIVE RADIOGRAPHS: THORACOLUMBAR CURVES 908 (738¿1088), 60% CORRECTION, THORACIC CURVES 768 (708¿1008), 46% CORRECTION, PELVIC OBLIQUITY 258 (68¿358), 51% CORRECTION. GROUP II, 2 (15%) CASES REQUIRED REMOVAL OF IMPLANTS. THIS REPORT REFERS TO COMPLICATIONS WITH GROUP II. 2 PATIENTS THAT NEEDED REMOVAL OF IMPLANTS DUE TO UNKNOWN REASONS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN VEPTR, UNKNOWN PART#/LOT#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173021 PROSTHESIS, RIB REPLACEMENT MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention