MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS; CREO MIS MODULAR POLYAXIAL TULIP, 30MM REDUCTION

Model Number	1134.0100
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The screw head popped off from the screw shank.This wasn't noticed until it was seen on the post-operative x-ray which was taken for reasons unrelated to the screw separation.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The implant was not returned for evaluation as they remain in the patient.No determinations can be made as to the cause of the reported issue.The following sections have been updated: b4, e1, e3, h2, h6, h10.

• Brand Name: CREO MIS
• Common Device Name: CREO MIS MODULAR POLYAXIAL TULIP, 30MM REDUCTION
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 18815497
• Report Number: 3004142400-2018-00015
• Device Sequence Number: 19914677
• Product Code: MNH
• UDI-Device Identifier: 00889095071146
• UDI-Public: 00889095071146
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1134.0100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American