MAUDE Adverse Event Report: NUVASIVE, INC. THORACOLUMBOSACRAL PEDICLE SCREW

Model Number 7880042

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Pain (1994); Disability (2371); Ambulation Difficulties (2544); Device Embedded In Tissue or Plaque (3165)

Event Date 06/17/2019

Event Type  Injury  

Event Description

Ten days after surgery two screws broke and are unable to be removed due to it will cause more damage.Reporter has had several surgeries since the initial, and states that he lives in pain everyday, is disabled and unable to walk without pain.

• Brand Name: THORACOLUMBOSACRAL PEDICLE SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW
• Manufacturer (Section D): NUVASIVE, INC.
• MDR Report Key: 9279478
• MDR Text Key: 165227108
• Report Number: MW5090865
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/04/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7880042
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 79 YR
• Patient Weight: 85