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

Model Number	1134.0100
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a creo mis screw head disassociated from the shank post operatively on an l3-5 fusion, causing subsequent rod migration on l4 and l5.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.The loose mis screw head showed marks on the distal face of its thread undercut on both sides of the rod slot.These marks are consistent with bottoming out or torquing of locking cap in it without a rod in place.The splaying of the screw head observed could have resulted from excessive or abnormal forces.This screw head also had its threads deformed only on one side of the rod slot.The saddle had wear marks only on one side suggesting that the rod or rod holder may have slipped off the screw head on that side before or during final tightening.The screw head may have inadvertently disassociated from the spherical screw head if it was not locked correctly to the screw head, or due to excessive/abnormal forces on the screw.However, no wear marks or signs suggesting forceful disassociation of a screw head with locked saddle from the screw spherical head were observed on its clamp's inner surface that mates with the screw's spherical head.All screw heads were able to be attached/detached (saddle locked/unlocked) from the returned screws during evaluation.The mis rod had wear on its surface covering a major potion of its surface area, suggesting rod slip.It is unclear whether the rod slipped during original implantation.The marks left by the l4 and l5 locking caps were relatively close to each other.The position where the l3 locking cap may have tightened on the rod was not clear.Any abnormal position of rod as suggested by the wear marks could affect the rod placement and final tightening at subsequent levels, which could lead to rod slippage.The mis locking cap had its thread starting to chipped off, and showed signs of uneven wear on its distal face.The threads were also deformed from excessive/uneven forces.It is unclear whether the locking cap may have cross threaded leading to the chipping and uneven wear on the screw head threads.The exact cause of the reported issue could not be determined.

• Brand Name: CREO STABILIZATION SYSTEM
• 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: 18834301
• Report Number: 3004142400-2023-00083
• Device Sequence Number: 7439476
• 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: 2022
• 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): 03/02/2024

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
• Device Lot Number: BAA574TH/BAA668DH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• 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: 63 YR
• Patient Sex: Unknown
• Patient Weight: 152 KG
• Patient Ethnicity: Hispanic