BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - MONO/POLYAXIAL SCREWS: USS

    MDR report key: 12348772 · Received August 20, 2021

    Report

    Report Number
    8030965-2021-06955
    Event Type
    Injury
    Date Received
    August 20, 2021
    Report Date
    July 22, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS REPORT IS FOR UNK - MONO/POLYAXIAL SCREWS: USS.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). PMA/510K: THIS REPORT IS FOR AN UNK - SCHANZ SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS 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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: AONO H., ET AL (2019) RISK FACTORS FOR A KYPHOSIS RECURRENCE AFTER SHORT-SEGMENT TEMPORARY POSTERIOR FIXATION FOR THORACOLUMBAR BURST FRACTURES, JOURNAL OF CLINICAL NEUROSCIENCE VOLUME 66, PAGES 138¿143 (JAPAN) HTTPS://DOI.ORG/10.1016/J.JOCN.2019.04.035. THIS PROSPECTIVE MULTICENTER STUDY AIMS TO INVESTIGATE THE RISK FACTORS FOR KYPHOSIS RECURRENCE AFTER TEMPORARY SHORT-SEGMENT FIXATION FOR THORACOLUMBAR BURST FRACTURES AND DETERMINED THE LIMITATIONS OF THE PROCEDURE. BETWEEN SEPTEMBER 2006 AND MAY 2016, 76 CONSECUTIVE PATIENTS (52 MALES, 24 FEMALES) WITH AN AVERAGE AGE OF 40 YEARS (RANGE, 13¿69 YEARS) IN WHOM A SINGLE THORACOLUMBAR BURST FRACTURE, WITH OR WITHOUT NEUROLOGICAL IMPAIRMENT, WAS DIAGNOSED WERE INCLUDED IN THIS STUDY. ALL SURGICAL PROCEDURES WERE PERFORMED UNDER CONTROLLED GENERAL ANESTHESIA. SCHANZ PEDICLE SCREWS (AO UNIVERSAL SPINE SYSTEM, DEPUY SYNTHES, WEST CHESTER, PA, USA) WITH A DIAMETER OF 6.2 OR 7.0 MM AND A THREAD LENGTH OF 35¿40 MM WAS USED BY OPEN PROCEDURE. IMPLANTS WERE REMOVED APPROXIMATELY 1 YEAR AFTER THE INITIAL OPERATION AFTER FRACTURE UNION, TO PRESERVE SEGMENT MOTION AND BECAUSE OF THE POSSIBILITY OF IMPLANT FAILURE. ALL PATIENTS WERE MONITORED CLINICALLY AND RADIOGRAPHICALLY FOR A MINIMUM OF 2 YEARS, WITH THE MEDIAN FOLLOW-UP DURATION BEING 40.6 MONTHS (RANGE, 24¿126 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED: LOSS OF CORRECTION WAS 0.4_ BEFORE IMPLANT REMOVAL, WHICH DETERIORATED BY ANOTHER 0.3 AFTER REMOVAL. TOTAL LOSS OF CORRECTION WAS 0.7 FROM THE INITIAL SURGERY. THE SIEA WAS CORRECTED FROM 13.4_ (RANGE, 29_ TO _16_) BEFORE SURGERY TO 1.6_ (RANGE, 24_ TO _24_) AFTER SURGERY. CORRECTION LOSS WAS 2.2_ BEFORE IMPLANT REMOVAL, AND IT DETERIORATED BY ANOTHER 6.9_ AFTER REMOVAL, MAKING THE TOTAL CORRECTION LOSS 9.1 FROM THE INITIAL SURGERY. 33 RECURRENCE OF KYPHOSIS. A CASE OF A 56-YEAR-OLD MALE BY 1 YEAR AFTER SURGERY, THERE HAD BEEN NO CHANGE IN EITHER ANGLE. BY 2 YEARS AFTER SURGERY, THE VBA REMAINED UNCHANGED BUT THE SIEA HAD CHANGED TO 14 (CORRECTION LOSS OF 7). THIS REPORT IS FOR AN UNKNOWN SYNTHES SPINE SCHANZ PEDICLE SCREWS. THIS REPORT IS FOR (1) UNK - SCHANZ SCREWS. THIS REPORT IS 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246418 UNK - MONO/POLYAXIAL SCREWS: USS ORTHOSIS, PEDICLE SPINAL FIXATION MNI SYNTHES GMBH
    1246419 UNK - MONO/POLYAXIAL SCREWS: USS ORTHOSIS, PEDICLE SPINAL FIXATION MNI SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention