BIOCORE
Report
- Report Number
- 2249852-2025-00014
- Event Type
- Injury
- Date Received
- June 6, 2025
- Report Date
- June 6, 2025
- Manufacturer
- COLLAGEN MATRIX, INC.
- Product Code
- MQV
- UDI-DI
- 00813954024769
- PMA / PMN Number
- K182074
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
THIS PARENT MDR IS MDR. THIS MDR IS FOR SUSPECT DEVICE 2.
COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY FURTHER INFORMATION SURROUNDING THE PATIENT OR THE EVENT WILL BE PROVIDED. PATIENT WAS DIAGNOSED WITH CHRONIC LOWER BACKPAIN. TWO ITEMS OF THE BIOCORE MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE WERE USED ON A PATIENT DURING INITIAL SURGERY ON (B)(6) 2024. PRODUCT WAS IMPLANTED IN PATIENT IN LOCATION L3-4 AND L4-5. A BONE MARROW ASPIRATE AND ALLOGRAFT (NOT COLLAGEN MATRIX, INC. PRODUCTS) WERE USED IN CONJUNCTION WITH THE BIOCORE BIOACTIVE PRODUCT. ADDITIONALLY, IT WAS REPORTED THAT INVICTUS SCREWS AND A CAGE WAS ALSO USED (NOT COLLAGEN MATRIX, INC. PRODUCTS). CUSTOMER REPORTED NO COMPLICATIONS WERE NOTED DURING IMPLANT AND THE PRODUCT HANDLED AND PERFORMED EXCELLENT. ON (B)(6) 2024 THERE WAS MILD ANTERIOR SUBSIDENCE OF THE L4-L5 CAGE INTO THE ANTERIOR L5 VERTEBRAL BODY. CUSTOMER CONFIRMED THIS WAS NOT A SERIOUS ADVERSE EVENT AND REPORTED PHYSICAL THERAPY AS THE BEHAVIORAL/LIFESTYLE INTERVENTION FOR THE PATIENT. CUSTOMER STATED PATIENT WAS TO START PHYSICAL THERAPY ON (B)(6) 2024. NO FURTHER DETAILS SURROUNDING OUTCOME OF PHYSICAL THERAPY, PATIENT STATUS, AND PATIENT OUTCOME WILL BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1463005 | BIOCORE | MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE | MQV | COLLAGEN MATRIX, INC. | 214-0060-ST | FB220502 | 00813954024769 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |