MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. GLOBUS CREO CANNULATED PEDICLE SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2021

Event Type  Injury  

Event Description

Locking cap from the spinal pedicle screw became loose from tulip head of spinal pedicle screw 3 months postop, requiring repeat surgery to reattach locking cap.Fda safety report id # (b)(4).

• Brand Name: GLOBUS CREO CANNULATED PEDICLE SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.
• MDR Report Key: 11372265
• MDR Text Key: 233555810
• Report Number: MW5099579
• Device Sequence Number: 1
• Product Code: NKB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 136