MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. MOBI-C; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Perforation (2001); Post Traumatic Wound Infection (2447)

Event Date 12/15/2017

Event Type  Injury  

Event Description

Health issues following implant of mobi-c device.Manifested by december of 17 then involvement in low speed car accident fully dislodged my device; punctured my esophagus and partially severe vocal cord.It was at this time we found the infection from surgery nearly two years prior.Cultures on device showed large presence of pathogen.Furthermore the cause of second spinal surgery was documented as device failure.

• Brand Name: MOBI-C
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.
• MDR Report Key: 7752264
• MDR Text Key: 116219354
• Report Number: MW5078863
• Device Sequence Number: 1
• Product Code: ODP
• 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: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• 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; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 35 YR
• Patient Weight: 86