MAUDE Adverse Event Report: LIFENET HEALTH VG2 CERVICAL; FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)

Catalog Number VG2C-T57P

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hematoma (1884); Nerve Damage (1979); Unspecified Immune System Problem (4435); Unspecified Respiratory Problem (4464); Swelling/ Edema (4577)

Event Date 12/14/2021

Event Type  Injury  

Event Description

I have five cadaver bones in my cervical spine and i'm developing autoimmune issues and thoracic spinal bone issues that were not there prior to the implant.I reached out to both lifenet health and musculoskeletal transplant foundation (mtf), and they refused to share the medical records and cause of death of the donors.I believe that the donors may have had covid vaccinations that could be affecting me or other illnesses.My fusion completely failed and never fused.The c3 cadaver bone feels like it's infected and swollen and it's pinching nerves in my spine.My body tried to reject the cadaver bones immediately.I end up having a stridor attack in the hospital and almost died at holy cross.The human body is smarter than any lab and i believe my body is not accepting these cadaver bones because they're diseased.Lifenet, i have two of your implants in my body and i would like all of the information about the donor because i am developing psoriatic arthritis and i believe it's an autoimmune reaction to the transplant from the cadaver donor.(b)(6).Subject: information on implants from donor.Mtf (musculoskeletal transplant foundation), i have three of your implants in my cervical spine from a surgery on (b)(6) 2021 at (b)(6) hospital with dr.(b)(6) as a surgeon.I am having autoimmune health issues ever since i've had the implants put in and would like all medical documentation including cause of death and illnesses associated with all of these cadaver bone donors.Odl spacer 8mm parallel, item 015108.Donor id: (b)(6).I ended up in icu (intensive care unit), had a surgery to remove the hematoma and woke up on a vent (ventilator).Mtf 1-800-433-6576.Reference reports: mw5118910, mw5118911, mw5118912, mw5118914.

• Brand Name: VG2 CERVICAL
• Type of Device: FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• Manufacturer (Section D): LIFENET HEALTH
• MDR Report Key: 17225004
• MDR Text Key: 318207638
• Report Number: MW5118913
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VG2C-T57P
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2023
• Patient Sequence Number: 1
• Treatment: MTF ODL; EMBROL ; PARALLEL 8MM; ZYRTEC
• Patient Outcome(s): Required Intervention; Disability; Other; Hospitalization; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White