BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CAGE/SPACER

    MDR report key: 11836421 · Received May 17, 2021

    Report

    Report Number
    1526439-2021-00954
    Event Type
    Injury
    Date Received
    May 17, 2021
    Report Date
    April 20, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    OVD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, AGE OR DATE OF BIRTH, SEX, AND WEIGHT: THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN CAGE/SPACER, UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN JULY 2012 AND OCTOBER 2013. 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. 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. 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: RICKERT M., (2019)CLINICAL OUTCOME AFTER ANTERIOR LUMBAR INTERBODY FUSION WITH A NEW OSTEOINDUCTIVE BONE SUBSTITUTE MATERIAL, CLIN SPINE SURG VOLUME 32, PAGES E319¿E325 (GERMANY). THIS STUDY AIMS TO CONDUCT A TRIAL OF NH-SIO2 EMBEDDED IN A POROUS SILICA GEL MATRIX IN PATIENTS UNDERGOING LUMBAR ALIF WITH A CARBON FIBER REINFORCED POLYMER CAGE, IN ORDER TO GUIDE FUTURE RESEARCH. BETWEEN JULY 2012 AND OCTOBER 2013, 40 PATIENTS WERE SCHEDULED TO UNDERGO SURGERY OF THE LUMBAR SPINE. PATIENTS WERE RANDOMIZED TO ALLOCATE THEM TO ALIF CAGE FILLED WITH EITHER NH-SIO2 WITH 20 PATIENTS (14 FEMALES, 6 MALES) AGE 60.6±12.5 YEAR OR HB AS FILLING MATERIAL WITH 20 PATIENTS (16 FEMALES, 4 MALES) AGE 66.1±9.6 .PATIENTS UNDERWENT MONOSEGMENTAL OR BISEGMENTAL SPONDYLODESIS AT THE LEVEL L4/L5 AND L5/S1 WITH A CARBON FIBER REINFORCED POLYMER ALIF CAGE (ALIF CFRP I/F CAGE, DEPUY SYNTHES INC., WARSAW, IN) FILLED WITH EITHER NH-SIO2 (NANOBONE PUTTY) OR HOMOLOGOUS BONE (HB) (TUTOPLAST TUTOGEN SPONGIOSA CHIPS,TUTOGEN MEDICAL GMBH, NEUNKIRCHEN AM BRAND,GERMANY).ALL PATIENTS WERE MONITORED UNTIL 12-MONTH FOLLOW-UP. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: N 2 PATIENTS IN THE NHSIO2 GROUP, DECOMPRESSION SURGERY OF THE NEUROFORAMEN WAS NECESSARY IN THE FIRST AND SEVENTH POSTOPERATIVE WEEK, RESPECTIVELY. IN THE NH-SIO2 GROUP, 1 ADDITIONAL PATIENT EXPERIENCED A PEDICLE FRACTURE 4 WEEKS POSTOPERATIVELY, WHICH REQUIRED OPERATIVE REVISION AND EXTENSION OF FUSION. IN THE HB GROUP, THERE WAS 1 CASE OF WOUND HEALING DISORDER, WHICH HEALED UNEVENTFULLY AFTER WOUND REVISION AND ANTIBIOTIC USE. THE IMPLANTS WERE LEFT IN SITU. LASTLY, FOR 1 PATIENT IN THE HB GROUP, AN ANTERIOR-POSTERIOR REVISION WITH CAGE REVISION WAS REQUIRED 3 MONTHS POSTOPERATIVELY BECAUSE OF NONUNION. PSEUDOARTHROSIS WAS ESTABLISHED BY FUNCTIONAL RADIOGRAPHS TAKEN AT THE 12-MONTH VISIT IN 1 SEGMENT IN THE NH-SIO2 GROUP AND IN 3 SEGMENTS (3 PATIENTS) IN THE HB GROUP (P=0.609). THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE CFRP I/F CAGE. THIS REPORT IS FOR ONE (1) UNKNOWN CAGE/SPACER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733343 UNKNOWN CAGE/SPACER INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR OVD DEPUY SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention