MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS 5.5MM CURVED ROD, TITANIUM ALLOY; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number 1134.7055

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2023

Event Type  Injury  

Event Description

Lumbar4-5 instrumented fusion performed (b)(6) 2022.On follow-up imaging after surgery there was noted to be a loose locking cap on the left at lumbar 4.Lumbar 4-5 left instrumentation revision performed (b)(6) 2023.

• Brand Name: CREO MIS 5.5MM CURVED ROD, TITANIUM ALLOY
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): GLOBUS MEDICAL, INC.
• MDR Report Key: 16488011
• MDR Text Key: 310853755
• Report Number: MW5115447
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1134.7055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 100 KG