BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CAGE/SPACERS: T-PAL

    MDR report key: 13591635 · Received February 24, 2022

    Report

    Report Number
    8030965-2022-01109
    Event Type
    Injury
    Date Received
    February 24, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNKNOWN CAGE/SPACERS: T-PAL/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE 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.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GIORGI, P, CAPITANI, D., AND SCHIRO, GR. (2015), USE OF A NOVEL POROUS HYDROXYAPETITE BONE GRAFT SUBSTITUTE IN POSTERO-LATERAL AND INTERBODY SPINAL FUSION: CLINICAL AND RADIOGRAPHOC ANALYSIS AT 4 YEAR FOLLOW UP, PROGRESS IN NEUROSCIENCE, VOL. 3, N. 1-4, PAGES 1-8 (ITALY). THE AIM OF THE PRESENT STUDY WAS TO EVALUATE THE USE OF A NOVEL CERAMIC-BASED HYDROXYAPATITE BONE GRAFT SUBSTITUTE IN FORM OF CHIPS, COMBINED WITH AUTOLOGOUS BONE, TO INDUCE BONY FUSION IN A SERIES OF PATIENTS UNDERGOING POSTEROLATERAL OR INTERBODY SPINAL FUSION. A TOTAL OF 36 PATIENTS UNDERWENT DECOMPRESSION AND SPINAL STABILIZATION WITH THE USE OF INSTRUMENTED FIXATION SUPPORTS IN ADDITION TO BONE GRAFT MATERIAL IN AT LEAST 1 SPINAL LEVEL BETWEEN T12 AND S1. ALL PATIENTS WERE DIVIDED INTO 2 GROUPS: POSTEROLATERAL (GROUP A; 8 MALES AND 11 FEMALES WITH AN AGE RANGE OF 45-70 YEARS) OR INTERBODY FUSION (GROUP B; 7 MALES AND 10 FEMALES WITH AN AGE RANGE OF 43-72 YEARS). THE IMPLANTS USED WERE URS SYSTEM FOR PEDICLE SCREW INSTRUMENTATION AND TPAL SPACER SYSTEMS FOR THE PEEK CAGES. FOLLOW-UP VISITS WERE CONDUCTED AT 6 WEEKS, 3, 6, 12, AND 48 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: GROUP A: 1 CASE HAD SCREW MOBILIZATION AND WAS TREATED WITH SURGICAL REVISION; 2 PATIENTS HAD NON FUSION. GROUP B: 1 PATIENT HAD A NON FUSION. THIS REPORT IS FOR AN UNKNOWN SYNTHESTPAL SPACER SYSTEM. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2099900 UNK - CAGE/SPACERS: T-PAL INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR OVD SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention