MAUDE Adverse Event Report: INFINITY LABORATORIES ORTHOFIX M6-C ARTIFICIAL CERVICAL DISC; PROSTHESIS, INTERVERTEBRAL DISC

Device Problems Unraveled Material (1664); Material Split, Cut or Torn (4008)

Patient Problems Pain (1994); Neck Pain (2433); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 04/13/2023

Event Type  Injury  

Event Description

On (b)(6) 2021, i had cervical disc replacement surgery on my c5/6 with orthofix m6-c, due to a herniated disc.Within about 9 months, i began to have pain going down my left arm and began having neck pain again.Although the migraines (that i was having before the surgery) never returned, i did begin having muscle spasms and tension in my neck that made my head hurt and interfered with my daily activities, as i often needed to rest in bed, off and on throughout the day, in order to feel better.Also, i took flexaril and lyrica to help the symptoms.On (b)(6) 2023 i went in to surgery with hopes of the pain being only from the other disc that was herniated (c 4/5).However, my orthopedic surgeon discovered that the orthofix m6's core and sheath, made of polycarbonate urethane, and the fiber surrounding the core, made of ultra-high molecular weight polyethylene, had begun coming undone and was also torn in several places.At this point, my surgeon decided to remove the orthofix m6-c and do a traditional 2-level acdf to my c5/6 and my c4/5.Although it's only the 16th day after surgery, my left arm pain is now completely gone, as well as all the other symptoms i was having.

• Brand Name: ORTHOFIX M6-C ARTIFICIAL CERVICAL DISC
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): INFINITY LABORATORIES
• MDR Report Key: 16887607
• MDR Text Key: 314848322
• Report Number: MW5117330
• Device Sequence Number: 1
• Product Code: MJO
• 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: 04/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White