MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO AMP 7.5X40MM MODULAR CANNULATED SCREW

Model Number	1067.4740
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision was needed to replace a creo screw that was found to have deviated post operatively.This event occurred in japan.
Additional Manufacturer Narrative
The device was available for evaluation.It was reported that a revision was needed to replace a creo screw that was found to have deviated post operatively.Visual inspection of the photos provided do not show any major damage or deformation that would indicate a catastrophic failure.From the information provided, the original l3-l5 plif surgery was completed on (b)(6) 2024 and a revision surgery was completed on (b)(6) 2024 due to a creo amp screw deviation.However, the surgeon was unable to disengage the independent lock during the revision case so the screw had to be removed and replaced.No x-ray images were provided for reference.The information provided confirmed the patient had osteoporosis.The deviation is consistent with osteoporotic bone.It was reported that when re-installing a deviated screw, it was difficult to set the rod due to the independent lock of the screw head.Eventually, the deviated (existing) screw could not be used and replaced it with a new reduction screw.Visual inspection of the returned implant show the mating creo amp screw still attached to reduction screw head.The parts are in the locked position with the saddle in the down position.There is not major signs of damage or deformation.There is some bio-debris visible between the saddle and screw head.The screw assembly was threaded into a holding block and the screw head was remobilized with a creo counter-torque and following the procedure detailed in the technique guide.Continued visual inspection of the screw head and screw do not show any abnormal damage or deformation to the internal components that would result in the screw head unable to be remobilized.No determinations could be made as to the cause of the reported issue.

• Brand Name: CREO
• Common Device Name: CREO AMP 7.5X40MM MODULAR CANNULATED SCREW
• 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: 19165799
• Report Number: 3004142400-2024-00069
• Device Sequence Number: 12621353
• Product Code: MNH
• UDI-Device Identifier: 00889095023862
• UDI-Public: 00889095023862
• 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: 2024
• 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): 04/22/2024

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: 1067.4740
• Device Lot Number: BAB606ND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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: Female
• Patient Race: Asian