MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED LOCKING CAP

Model Number	1119.0010
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.Initial observation shows multiple signs of wear.The left l3 locking cap was reported loose and had a single channel worn into its base.The right side l2 and l3 locking caps showed signs of wear all the way around their bottoms and were also reported loose.All the threads of all the returned locking caps showed normal signs of wear with no significant signs of deformation.The right l2 and l3 screws that were returned did not show any signs of deformation within the tulip threads or any signs of splay.A gray lubricious substance was found within both screws near the saddles.The signs of wear around the bases of the right l2 and l3 locking caps indicate that the caps backed out.The channel within the l3 locking cap indicates that the rod was able to slide back and forth to wear a space within the cap.No determinations could be made as to the cause of the reported issue.The following sections have been updated: b4, d4, d9, g6, h2, h3, h6, h10 and b4, e1, g6, h2, h6, h10.
Event or Problem Description
It was reported there was a revision surgery due to creo threaded locking caps that were found loose post operatively with subsequent rod displacement, causing patient pain.This event occurred in ireland.

• Brand Name: CREO
• Common Device Name: CREO THREADED LOCKING CAP
• 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: 18837893
• Report Number: 3004142400-2023-00153
• Device Sequence Number: 15265432
• Product Code: MNH
• UDI-Device Identifier: 00889095059496
• UDI-Public: 00889095059496
• 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
• 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): 03/01/2024

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: 1119.0010
• Device Lot Number: BAA847SD/BAA807DD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 14 YR
• Patient Sex: Female
• Patient Weight: 45 KG
• Patient Race: White