BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

    MDR report key: 8570819 · Received May 1, 2019

    Report

    Report Number
    2939274-2019-57765
    Event Type
    Injury
    Date Received
    May 1, 2019
    Report Date
    April 3, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: USS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). 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: JOHN S. THALGOTT ET. AL (2001), INSTRUMENTED POSTEROLATERAL LUMBAR FUSION USING CORALLINE HYDROXYAPATITE WITH OR WITHOUT DEMINERALIZED BONE MATRIX, AS AN ADJUNCT TO THE AUTOLOGOUS BONE, THE SPINE JOURNAL, VOL. 1(2), PAGES 131-137 (USA) HTTPS://DOI.ORG/10.1016/S1529-9430(01)00011-0. THE AIM OF THIS ARTICLE IS TO DETERMINE THE EFFICACY OF CORALLINE HYDROXYAPATITE WITH OR WITHOUT DEMINERALIZED BONE MATRIX AS A BONE GRAFT EXTENDER IN A HUMAN CLINICAL MODEL WITH LONG-TERM FOLLOW-UP. A TOTAL OF 40 PATIENTS (14 MALE AND 26 FEMALE) WITH A MEAN AGE OF 62 YEARS (RANGE, 25-77YEARS) WERE INCLUDED IN THE STUDY. ALL PATIENTS UNDERWENT TRANSPEDICULAR FIXATION WITH AUTOGENOUS POSTEROLATERAL LUMBAR FUSION. ALL PATIENTS WERE IMPLANTED WITH SYNTHES USS. THE MEAN DURATION OF FOLLOW-UP WAS 53 MONTHS WITH A RANGE OF 28-70 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 2 PATIENTS HAD 2 DORAL TEARS. 1 PATIENT HAD ONE-FOOT DROP WHICH DID NOT RESOLVE. 5 PATIENTS HAD CONTINUED PAIN AND SUSPECTED PSEUDARTHROSIS WAS 4 PATIENTS FOUND TO BE SOLIDLY FUSED BY DIRECT EXPLORATION OF THE FUSION MASS. 6 PATIENTS EXPERIENCE EXCELLENT PAIN (TABLE 2). 12 PATIENTS EXPERIENCE GOOD PAIN (TABLE 2). 10 PATIENTS EXPERIENCE FAIR PAIN (TABLE 2). 12 PATIENTS EXPERIENCE POOR PAIN. (TABLE 2). AN (B)(6) FEMALE PATIENT HAD A HARDWARE REMOVAL DUE TO RESIDUAL LEG PAIN AND THE DESIRE TO REMOVE THE HARDWARE. A (B)(6) PATIENT HAS THE SCREW AT L2 APPEAR TO BE VIOLATING THE DISC SPACE. 1 PATIENT HAD A MALPOSITIONED SCREW. 1 PATIENT HAD RETAINED BROKEN SCREW. 1 PATIENT HAD PARTIAL REMOVAL. (B)(6) ARTHRITIC MALE PATIENT ((B)(6) AT THE TIME OF FOLLOW-UP) PRESENTING WITH FAILED LAMINECTOMY SYNDROME AND SPINAL STENOSIS. A (B)(6) MAN ((B)(6) AT THE TIME OF FOLLOW-UP) PRESENTING WITH A PRIOR PSEUDARTHROSIS AND FAILED LAMINECTOMY SYNDROME AT L4¿5 AND L5¿S1. THE PATIENT WAS INSTRUMENTED WITH SUBSEQUENT POSTEROLATERAL FUSION. NO GRAFTON DBM WAS USED. THE RADIOGRAPH CLEARLY SHOWS PARTIAL RESORPTION ON THE RIGHT. THIS PATIENT WAS JUDGED TO BE SOLIDLY FUSED AT BOTH LEVELS DESPITE THE PARTIAL RESORPTION. THIS REPORT IS FOR A SYNTHES UNIVERSAL SPINE SYSTEM- CONSTRUCTS: USS. THIS IS REPORT 5 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362700 ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention