BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILLER, CALCIUM SULFATE PREFORMED PELLETS

    MDR report key: 7527081 · Received May 18, 2018

    Report

    Report Number
    2939274-2018-52232
    Event Type
    Injury
    Date Received
    May 18, 2018
    Report Date
    May 1, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K: THIS REPORT IS FOR AN UNKNOWN SYNTHES CHRONOS BONE GRAFT SUBSTITUTE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: PAKZABAN, P. (2016), MODIFIED MINI-OPEN TRANSFORAMINAL LUMBAR INTERBODY FUSION, JOURNAL OF SPINE SURGERY, VOL. 41 NO. 18, PAGES E1124-E1130 (UNITED STATES OF AMERICA). THIS RETROSPECTIVE STUDY AIMS TO DESCRIBE A MODIFIED TECHNIQUE FOR MINI-OPEN TRANSFORAMINAL LUMBAR INTERBODY FUSION, TLIF (MOTLIF) THAT IMPROVES VISUALIZATION FOR DECOMPRESSION, FUSION, AND FREEHAND PEDICLE SCREW INSERTION AS WELL AS TO ASSESS THE ACCURACY OF FREEHAND PEDICLE SCREW PLACEMENT. BETWEEN 2008 AND 2012, NINETY-TWO PATIENTS (40 MALES AND 52 FEMALES WITH THE MEAN AGE OF 53 YEARS) HAD UNDERGONE MOTLIF PROCEDURES. A SMALL PIECE OF BETA TRICALCIUM PHOSPHATE BONE SUBSTITUTE SYNTHES CHRONOS WAS WEDGED UNDER THE ANNULUS TO KEEP THE BONE PIECES IN PLACE. MEAN FOLLOW-UP WAS 35 MONTHS WITH A MINIMUM FOLLOW-UP OF 2 YEARS. DYNAMIC RADIOGRAPHS WERE PERFORMED PREOPERATIVELY, AT 3 AND 6 MONTHS POSTOPERATIVELY, AND AT 6-MONTH INTERVALS THEREAFTER, UNTIL FUSION WAS ACHIEVED. COMPUTED TOMOGRAPHY (CT) OF THE LUMBAR SPINE WAS SCHEDULED AT 12 MONTHS POSTOPERATIVELY TO ASSESS FUSION. THE AUTHOR REPORTED THE FOLLOWING EVENTS ASSOCIATED WITH MOTLIF: THE 5 PATIENTS HAD WOUND ERYTHEMA WHICH WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS THE 1 PATIENT HAD A DEEP WOUND INFECTION WHICH WAS SUCCESSFULLY TREATED SURGICAL DEBRIDEMENT AND 4 WEEKS OF INTRAVENOUS ANTIBIOTIC THERAPY WITHOUT REMOVAL OF THE HARDWARE. THE 4 PATIENTS HAD FUSION FAILURE REQUIRING REVISION. 3 PATIENTS HAD INCIDENTAL DUROTOMIES THAT WERE REPAIRED INTRAOPERATIVELY. THIS REPORT IS FOR AN UNKNOWN SYNTHES CHRONOS BONE GRAFT SUBSTITUTE. THIS IS REPORT 1 OF 1 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368784 FILLER, CALCIUM SULFATE PREFORMED PELLETS MQV WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention