MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. / LDR MEDICAL MOBI-C CERVICAL DISC PROSTHESIS; PROSTHESIS INTERVERTEBRAL DISC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Disability (2371)

Event Date 09/21/2018

Event Type  Injury  

Event Description

I received 2 disc replacements in my neck c4-5 and c 5-6 of the mobi-c on (b)(6) 2018 and had severe problems that caused a second surgery on (b)(6) 2018 to rereplace the replacements and now (b)(6) 2019 i am still experiencing nerve issue and doctor is now talking about a fusion.I am permanently disable now or, so i feel that way.Did the problem stop after the person reduced the dose or stopped taking or using the product? no; did the problem return if the person started taking or using the product again? no; date the person first started taking or using the product: (b)(6) 2018.

• Brand Name: MOBI-C CERVICAL DISC PROSTHESIS
• Type of Device: PROSTHESIS INTERVERTEBRAL DISC
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC. / LDR MEDICAL
• MDR Report Key: 8227603
• MDR Text Key: 132579285
• Report Number: MW5082909
• 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: Other
• Type of Report: Initial
• Report Date: 01/04/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 40 YR
• Patient Weight: 86