MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO AMP 6.5X45MM MODULAR CANNULATED SCREW

Model Number	1067.4645
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Neither the device nor any images were available for evaluation.It was reported that a revision surgery was needed due to two 1067.4645 creo amp 6.5x45mm modular cannulated screws that were found to have pulled out of bone post-operatively.The initial surgery, a psf with t12-l3 screws and 10mm screw head, was performed on (b)(6) 2022.On (b)(6) 2023 it was found that the t12 screws pulled out of bone.A revision surgery, t11-l3, was conducted on (b)(6) 2023 to address bilateral loose t12 screws, adjacent segment disease (asd) at t11/12, and radiculopathy at l4/5.During the surgery the t12 screws were replaced and screws were added to extend the construct to t11.The me-mild technique was then used to decompress the neural elements at t11/12 and l4/5.The patient's reported osteoporosis likely caused the screw loosening at t12.No other determinations could be made as to the cause of the reported issue.(b)(6).
Event or Problem Description
It was reported that a revision was needed due to creo screws found loose both operatively.This event occurred in japan.

• Brand Name: CREO
• Common Device Name: CREO AMP 6.5X45MM 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: 18809569
• Report Number: 3004142400-2023-00185
• Device Sequence Number: 7248781
• Product Code: MNH
• UDI-Device Identifier: 00889095023688
• UDI-Public: 00889095023688
• 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: 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): 02/28/2024

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: 1067.4645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 02/29/2024
• 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: Female
• Patient Race: Asian