MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO MIS MODULAR POLYAXIAL TULIP, 10MM REDUCTION

Model Number	1134.0110
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation as it was discarded by the hospital.An initial surgery was performed on (b)(6) 2023 with creo mis screws on levels l4-s1 using excelsiusgps robot, with 2 alif cages at levels l4l5 and l5s1.It was reported that the surgeon had used counter-torque and stabilizer cuffs during final tightening.The patient was reported to have a higher bmi.A revision surgery was conducted on (b)(6)2023 due to interbody implant subsidence at l5-s1 and the s1 creo mis tulip disassociating from the screw shank post operatively.The s1 tulip and screw was removed and replaced with a bigger screw with creo mis tulip.The construct was extended to s2 level using creo s2ai.It was confirmed that no issues were found with the head inserter.The reported screw head disassociation may occur due to excessive post-operative forces or forces related to the interbody implant subsidence, improper head insertion of the tulip to the screw shank, or excessive intra-operative forces.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision was performed to remove a creo mis screw head that had separated from the shank post operatively.This event occurred in australia.

• Brand Name: CREO
• Common Device Name: CREO MIS MODULAR POLYAXIAL TULIP, 10MM 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: 18562910
• Report Number: 3004142400-2024-00014
• Device Sequence Number: 15167956
• Product Code: MNH
• UDI-Device Identifier: 00889095071153
• UDI-Public: 00889095071153
• 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: 2023
• 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): 01/22/2024

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: 1134.0110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 01/23/2024
• 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 Sex: Unknown