BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCORE

    MDR report key: 19271484 · Received May 8, 2024

    Report

    Report Number
    2249852-2024-00007
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    February 20, 2024
    Report Date
    June 10, 2024
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    MQV
    UDI-DI
    00813954024775
    PMA / PMN Number
    K182074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR (2249852-2024-00007) IS FOR SUSPECT DEVICE 1 AND IS THE PARENT MDR. PLEASE REFER TO MDR NUMBER 2249852-2024-00008 FOR THE OTHER REPORTED SUSPECT DEVICE. THE PRODUCT MET ACCEPTANCE CRITERIA AND WAS RELEASED WITH CONFORMING ROUTINE TESTING RESULTS.

    Description of Event or Problem · 0

    COMPLAINT WAS RECEIVED THROUGH A CLINICAL DATA COLLECTION. PATIENT DIAGNOSED WITH SPONDYLOLISTHESIS (LUMBAR REGION) AND LUMBAR SPINAL STENOSIS. THE CUSTOMER REPORTED THE BIOCORE PRODUCT WAS USED FOR A POSTEROLATERAL SPINE PROCEDURE ON (B)(6) 2024. TWO ITEM NUMBERS OF BIOCORE PRODUCT WERE PROVIDED BY THE CUSTOMER AND CONFIRMED TO BE USED ON THE PATIENT AT THE SAME TIME FOR THE PROCEDURE. THE BIOCORE PRODUCT WAS IMPLANTED AT VERTEBRAE SITES 3-4 AND 4-5, HOWEVER IT WAS NOT SPECIFIED WHICH PRODUCT WAS UTILIZED AT WHAT VERTEBRAE SITE. THE BIOCORE PRODUCT WAS MIXED WITH BONE MARROW ASPIRATE. ATEC SCREWS AND EXPANDABLE CAGES WERE ALSO USED DURIGN THE PROCEDURE - ONLY THE BIOCORE PRODUCT IS MANUFACTURED BY COLLAGEN MATRIX, INC. THE PATIENT'S L3-L4 INTERBODY CAGE HAS BEEN DISPLACED POSTERIORLY, CONFIRMED BY RADIOGRAPHS TAKEN ON (B)(6) 2024. THE INTERBODY CAGE THAT WAS DISPLACED IS NOT MANUFACTURED BY COLLAGEN MATRIX, INC. DURING THE (B)(6) 2024 FOLLOW-UP VISIT THE PATIENT WAS REPORTED TO BE "DOING EXTREMELY WELL POSTOPERATIVELY." NO SIGNIFICANT PAIN REPORTED. THE PATIENT HAD REVISION SURGERY PERFORMED ON (B)(6) 2024. REVISION SURGERY CONSISTED OF THE FOLLOWING SURGERIES: (1) EXPLORATION OF SPINAL FUSION L3-L4, L4-L5; (2) REMOVAL OF L3-L4 POSTERIORLY DISPLACED/MIGRATED INTERBODY CAGE; AND (3) REVISION TRANSFORAMINAL LUMBAR INTERBODY AND POSTERIOR FUSION L3-L4 WITH USE OF NEW INTERBODY CAGE, AUTOGRAFT, ALLOGRAFT. NO COMPLICATIONS FROM REVISION SURGERY REPORTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2024. NO FURTHER INFORMATION ON PATIENT STATUS WAS PROVIDED.

    Description of Event or Problem · 0

    COMPLAINT WAS RECEIVED THROUGH A CLINICAL DATA COLLECTION. PATIENT DIAGNOSED WITH SPONDYLOLISTHESIS (LUMBAR REGION) AND LUMBAR SPINAL STENOSIS. THE CUSTOMER REPORTED THE BIOCORE PRODUCT WAS USED FOR A POSTEROLATERAL SPINE PROCEDURE ON (B)(6) 2024. TWO ITEM NUMBERS OF BIOCORE PRODUCT WERE PROVIDED BY CUSTOMER AND CONFIRMED TO BE USED ON THE PATIENT AT THE SAME TIME FOR THE PROCEDURE. THE BIOCORE PRODUCT WAS IMPLANTED AT VERTEBRAE SITES 3-4 AND 4-5, HOWEVER IT WAS NOT SPECIFIED WHICH PRODUCT WAS UTILIZED AT WHAT VERTEBRAE SITE.THE BIOCORE PRODUCT WAS MIXED WITH BONE MARROW ASPIRATE. ATEC SCREWS AND EXPANDABLE CAGES WERE ALSO USED IN CONJUNCTION WITH THE PRODUCT - THESE DEVICES ARE NOT MANUAFCTURED BY COLLAGEN MATRIX, INC. THE PATIENT'S L3-L4 INTERBODY CAGE HAS BEEN DISPLACED POSTERIORLY, CONFIRMED BY RADIOGRAPHS TAKEN ON (B)(6) 2024. THE INTERBODY CAGE THAT WAS DISPLACED IS NOT MANUFACTURED BY COLLAGEN MATRIX, INC. DURING THE (B)(6) 2024 FOLLOW-UP VISIT PATIENT WAS "DOING EXTREMELY WELL POSTOPERATIVELY." NO SIGNIFICANT PAIN REPORTED. NO COMPLICATIONS REPORTED DURING INITIAL IMPLANTATION. CUSTOMER CONFIRMED PRODUCT HANDLED AND PERFORMED EXCELLENT. CUSTOMER CONFIRMED REVISION SURGERY WILL BE REQUIRED AT A LATER TIME, HOWEVER NO INFORMATION SURROUNDING THE CONFIRMED REVISION SURGERY WAS PROVIDED (NATURE OF REVISION SURGERY, OUTCOME OF REVISION SURGERY NOT PROVIDED). NO FURTHER INFORMATION ON PATIENT STATUS WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99996 BIOCORE MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE MQV COLLAGEN MATRIX, INC. 214-0120-ST FB221001 00813954024775

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| O