BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CAGE/SPACER: PEEK

    MDR report key: 14073878 · Received April 11, 2022

    Report

    Report Number
    1526439-2022-00551
    Event Type
    Injury
    Date Received
    April 11, 2022
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER, AGE OR DATE OF BIRTH, SEX, WEIGHT: THERE ARE MULTIPLE PATIENTS. ALL KNOWN INFORMATION IS PROVIDE IN THE LITERATURE ARTICLE. THIS REPORT IS FOR AN UNKNOWN PEEK CAGE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATED BY MFR AND MANUFACTURE DATE: 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.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ADL AMIN D., ET AL (2021) EARLY OUTCOMES OF THREE-DIMENSIONAL-PRINTED POROUS TITANIUM VERSUS POLYETHERETHERKETONE CAGE IMPLANTATION FOR STAND-ALONE LATERAL LUMBAR INTERBODY FUSION IN THE TREATMENT OF SYMPTOMATIC ADJACENT SEGMENT DEGENERATION, WORLD NEUROSURGERY VOLUME XXXX , PAGES 1-7 (GERMANY). THIS RETROSPECTIVE STUDY AIMS TO COMPARE RADIOLOGICAL AND CLINICAL OUTCOMES OF TI VERSUS PEEK CAGE IMPLANTATION FOR STAND-ALONE LATERAL LUMBAR INTERBODY FUSION (SA-LLIF) IN THE TREATMENT OF SYMPTOMATIC ADJACENT SEGMENT DEGENERATION (ASD) WITH A MINIMUM FOLLOW-UP OF 6 MONTHS. BETWEEN OCTOBER 2016 AND JULY 2020, 44 DATA OF PATIENTS (23 MALES AND 21 FEMALES) AGE AT SURGERY 61- 11.6 YEARS UNDERGOING SA-LLIF FOR TREATMENT OF SYMPTOMATIC ASD AT A SINGLE ACADEMIC INSTITUTION MET INCLUSION CRITERIA WERE INCLUDED IN THE STUDY. ALL PATIENTS UNDERWENT SA-LLIF IN THE ADJACENT SEGMENT USING EITHER 1 OF 2 PEEK CAGE SYSTEMS (XLIF [NUVASIVE, INC., SAN DIEGO, CALIFORNIA, USA] OR COUGAR SYSTEM [DEPUY SPINE LLC, RAYNHAM, MASSACHUSETTS, USA]) OR 1 OF 2 TI CAGE SYSTEMS ([MODULUS XLIF (NUVASIVE, INC.] OR LATERAL SPINE TRUSS SYSTEM (4WEB MEDICAL, INC., FRISCO, TEXAS, USA). OF THE 59 LEVELS TREATED, 25 WERE TREATED USING TI CAGES, AND 34 WERE TREATED USING PEEK CAGES. DURING SURGERY, ALL CAGES WERE FILLED WITH BMP-2, AND 2 PATIENTS HAD BOTH BMP-2 AND DEMINERALIZED ALLOGRAFT. THE MEAN RADIOLOGICAL FOLLOW-UP BETWEEN SURGERY AND ASSESSMENT OF RADIOLOGICAL OUTCOMES WAS 12.5 -8.3 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED: CAGE SUBSIDENCE: (N=14) GRADE I, (N=4) GRADE II, (N=2) GRADE III. HIGH-GRADE SUBSIDENCE (GRADES II AND III): (N=20) GRADE I-III, AND (N=6) GRADE II-III. AFTER AN AVERAGE CLINICAL FOLLOW-UP OF 11.0 -7.1 MONTHS, REVISION SURGERY OWING TO HIGH-GRADE SUBSIDENCE WAS RECOMMENDED TO 3 PATIENTS. TWO PATIENTS IN THE UNDERWENT REVISION SURGERY WITH ADDITIONAL POSTERIOR PEDICLE SCREW FIXATION. AFTER AN AVERAGE CLINICAL FOLLOW-UP OF 11.0 -7.1 MONTHS, REVISION SURGERY TO SEVERE BACK PAIN. INTERVENTIONAL PAIN THERAPY OWING TO PERSISTENT OR WORSENING BACK PAIN WAS RECOMMENDED FOR 2 PATIENTS. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE PEEK CAGE (COUGAR) AND CAPTURES CAGE SUBSIDENCE AND REVISION SURGERY OWING TO HIGH-GRADE SUBSIDENCE; TWO PATIENTS UNDERWENT REVISION SURGERY WITH ADDITIONAL POSTERIOR PEDICLE SCREW FIXATION. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822328 UNK - CAGE/SPACER: PEEK INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention