MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO AMP THREADED POLYAXIAL TULIP

Model Number	1119.0110
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices was available for evaluation along with associated parts including a single creo threaded locking cap, a single 5.5mm curved rod, titanium alloy, 100mm length, and a single creo one 7.5x35mm robotic, self-drilling, modular screw.It was reported that the screw head disconnected from the screw at the right side s1 on an l3-s1 construct originally completed on (b)(6) 2022.The patient had a revision/extension of the fusion from l2-pelvis done on (b)(6) 2024.During the surgery is when the screw head was found to be disassociated from the screw shank.Review of the provided ct section shows the head of the screw within s1 is dissociated from screw shank.All parts were evaluated and imaging was taken.Visual inspection indicated that the head of the screw shows significant wear along where the screw head is attached and within the hexalobe feature.One of the clamps has been completely fractured perpendicular to the axis of the screw assembly.The other clamp shows a fracture half way through the same perpendicularity.The bottom of the saddle exhibits deep gashes and signs of deformation and these same marks can be seen on the tops of the clamps that connect to the same region where deformation is present.The body of the screw head exhibits signs of deformation along the bottom ring and a deep gash within one of the sides.Fracture and dissociation are indicative of high forces or repetitive stresses being placed on the screws and a lack of fusion over time.The orientation of the fractured clamps are consistent with exposure to high forces which is possible at the ends of a screw construct.However, it is unknown exactly how this failure may have occurred or which factors were the primary contributors to the failure.The surgical and post-operative conditions cannot be replicated, therefore, no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during a revision surgery a creo amp threaded polyaxial screw head was found separated from the implant post operatively.

• Brand Name: CREO
• Common Device Name: CREO AMP THREADED POLYAXIAL TULIP
• 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: 18734419
• Report Number: 3004142400-2024-00036
• Device Sequence Number: 20417049
• Product Code: MNH
• UDI-Device Identifier: 00889095059656
• UDI-Public: 00889095059656
• 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
• Device Explanted Year: 2024
• 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): 02/19/2024

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: 1119.0110
• Device Lot Number: BAA826NG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• 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 Sex: Unknown