BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 8668521 · Received June 4, 2019

    Report

    Report Number
    2210968-2019-82370
    Event Type
    Injury
    Date Received
    June 4, 2019
    Report Date
    May 8, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: OPER TECH ORTHOP. 2005; 15: 315-325. DOI: 10.1053/(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: OPERATIVE STRATEGIES FOR THORACIC INSUFFICIENCY SYNDROME BY VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB EXPANSION THORACOPLASTY. AUTHORS: ROBERT M. CAMPBELL, JR, MD. CITATION: OPER TECH ORTHOP. 2005; 15: 315-325. DOI: 10.1053/J.OTO.2005.08.008. THE 3-DIMENSIONAL THORACIC DEFORMITY RESPONSIBLE FOR THORACIC INSUFFICIENCY SYNDROME IN CHILDREN CAN BE ADDRESSED BY CORRECTING THE RESPECTIVE VOLUME DEPLETION DEFORMITY THROUGH VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) EXPANSION THORACOPLASTY. THESE DEFORMITIES INCLUDE ABSENT RIBS, FUSED RIBS AND SCOLIOSIS, WINDSWEPT DEFORMITY OF THE THORAX IN EARLY ONSET SCOLIOSIS, AND HYPOPLASTIC THORAX. THE CORE PRINCIPLE OF THIS SURGICAL TECHNIQUE IS THE EARLY RESTORATION OF MAXIMUM VOLUME AND SYMMETRY OF THE THORAX WITH INDIRECT CORRECTION OF THE SCOLIOSIS WITHOUT THE GROWTH INHIBITION EFFECTS OF SPINE SURGERY. A TOTAL OF 27 PATIENTS WITH CONGENITAL SCOLIOSIS AND FUSED RIBS WERE INCLUDED IN THE STUDY. DURING THE SURGICAL PROCEDURE, A SECTION OF 1 OR 2 FUSED RIBS FROM THE SUPERIOR OR INFERIOR BORDER OF THE THORACOSTOMY IS OSTEOTOMIZED FREE WITH THE MEDIAL ATTACHMENT INTACT, AND THEN ROTATED CENTRALLY INTO THE CHEST WALL DEFECT. THIS SECTION OF OSTEOTOMIZED RIBS IS THEN SUTURED CENTRALLY TO THE RIB PROSTHESIS WITH PROLENE SUTURE (ETHICON). THE INFERIOR SPINAL HOOK IS THEN STABILIZED BY WRAPPING A NONABSORBABLE SUTURE, SUCH AS PROLENE 1-0 (ETHICON), AROUND THE ROD, JUST SUPERIOR TO THE HOOK, AND PASSING THE SUTURE UNDERNEATH THE POSTERIOR SPINOUS PROCESS. REPORTED COMPLICATIONS INCLUDED SLOW ASYMMETRIC MIGRATION OF THE SUPERIOR CRADLE OF THE HYBRID DEVICE THROUGH THE PROXIMAL RIBS OF ATTACHMENT AND ALL WERE DISCOVERED FORTUITOUSLY ON PREOPERATIVE X-RAYS FOR SCHEDULED EXPANSION PROCEDURES AND THESE SUPERIOR RIB CRADLES WERE EASILY RESEATED THROUGH 4-CM INCISIONS, THE SPINAL HOOK MIGRATED POSTERIOR-INFERIORLY WITH COMPLETE DISENGAGEMENT AND ALL WERE RESEATED THROUGH LIMITED INCISION, SKIN SLOUGH (N-4) WHICH WERE TREATED WITH DEBRIDEMENT AND PRIMARY CLOSURE WITH ONE REQUIRING TEMPORARY REMOVAL OF DEVICE AND LATER RE-INSERTION, AND INFECTION (N-3) WHICH REQUIRED DEBRIDEMENT AND INTRAVENOUS ANTIBIOTICS. VEPTR EXPANSION THORACOPLASTY CAN CONTROL EXOTIC SCOLIOSIS IN PATIENTS WITH CONGENITAL SCOLIOSIS AND FUSED RIBS WITH IMPROVEMENT IN THE CORONAL PLANE OF THE 3-DIMENSIONAL THORACIC DEFORMITY AND STABILIZATION OF THE TRANSVERSE PLANE THREE-DIMENSIONAL DEFORMITY OF THE THORAX. VITAL CAPACITIES AT SHORT TERM FOLLOW-UP ARE ACCEPTABLE, ESPECIALLY IN THOSE PATIENTS WHO WERE YOUNGER THAN AGE 2 YEARS AT TIME OF THEIR INITIAL SURGERY WITH NO HISTORY OF PRIOR SPINAL SURGERY. ADDITIONAL VEPTR EXPANSION THORACOPLASTIES HAVE BEEN DEVELOPED FOR TREATMENT OF THORACIC INSUFFICIENCY SYNDROME ASSOCIATED WITH OTHER VOLUME DEPLETION DEFORMITIES OF THE THORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459889 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention