MAUDE Adverse Event Report: SPINAL SYSTEM; APPLICANCE, FIXATION, SPINAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Event Description

Spine surgery (metal rods, metal cages, screws, artificial implants) failure completely without medical relief or resolution.Medications are necessary and permanent and/or permanent pain treatments daily.Extreme difficulty with physical movement.Assistance needed with this question.

• Brand Name: SPINAL SYSTEM
• Type of Device: APPLICANCE, FIXATION, SPINAL
• MDR Report Key: 8301543
• MDR Text Key: 135741996
• Report Number: MW5083677
• Device Sequence Number: 1
• Product Code: PWG
• 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: 01/25/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Weight: 70