BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RODS

    MDR report key: 9238473 · Received October 25, 2019

    Report

    Report Number
    1526439-2019-52287
    Event Type
    Injury
    Date Received
    October 25, 2019
    Report Date
    October 21, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 REVIEW OF THE FOLLOWING JOURNAL ARTICLE: NEWTON,P., PARENT, S., MARKS, M. & PAWELEK, J. (2005), PROSPECTIVE EVALUATION OF 50 CONSECUTIVE SCOLIOSIS PATIENTS SURGICALLY TREATED WITH THORACOSCOPIC ANTERIOR INSTRUMENTATION, SPINE VOLUME 30, NUMBER 17S, PP S100¿S109 (USA). THE PURPOSE OF THIS EVALUATION IS TO REPORT A SINGLE SURGEON'S EXPERIENCE WITH AN INITIAL SERIES OF 50 PATIENTS. THE GOAL IS TO REPORT THE OUTCOMES WITH REGARDS TO THE RADIOGRAPHIC FINDINGS, PULMONARY FUNCTION, AND THE SRS OUTCOMES INSTRUMENT, AS WELL AS A REVIEW OF THE PERIOPERATIVE DATA AND THE SERIES CONSISTED OF 44 FEMALES AND 6 MALES WITH A MEAN AGE OF 14 YEARS (RANGE, 9-48 YEARS). FORTY-FIVE OF THE 50 PATIENTS WERE AVAILABLE FOR CLINICAL AND RADIOGRAPHIC EVALUATION AT GREATER THAN OR EQUAL TO 2 YEARS AFTER SURGERY. THE AVERAGE LENGTH OF FOLLOW-UP FOR THESE 45 PATIENTS WAS 33 MONTHS (RANGE, 2-5 YEARS). THE MEAN OPERATIVE TIME FOR THE PROCEDURE WAS 350 +/- 50 MINUTES AND RANGED FROM 265 TO 528 MINUTES. THE ESTIMATED INTRAOPERATIVE BLOOD LOSS AVERAGED 431 +/- 273 ML (RANGE, 75-1,400 ML). NORMALIZING THE OPERATIVE TIME AND ESTIMATED BLOOD LOSS BASED ON THE NUMBER OF LEVELS TREATED RESULTED IN AN AVERAGE OPERATIVE TIME PER LEVEL OF 48 +/- 6 MINUTES PER LEVEL AND AN ESTIMATED INTRAOPERATIVE BLOOD LOSS PER LEVEL OF 60 +/- 37 ML PER LEVEL. THE PREOPERATIVE THORACIC COBB AVERAGED 53 DEGREES +/- 9 DEGREES (RANGE, 40 DEGREES-80 DEGREES). AT MOST RECENT FOLLOW-UP (> OR = 2 YEARS), THE THORACIC COBB AVERAGED 24 DEGREES +/- 7 DEGREES. IMPLANT FAILURE OCCURRED IN 3 CASES. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: DEPUY SPINE PRODUCT: THIS REPORT IS FOR MOSS-MIAMI AND FRONTIER ROD SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033892 UNKNOWN RODS UNKNOWN HSB DEPUY SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other