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

Model Number	1067.1645
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.A creo amp 6.5x45mm modular screw shaft and a polyaxial threaded tulip were received for evaluation.It was reported that a revision surgery was needed due a creo amp screw touching a nerve root.Visual inspection of the assembled screw showed deformation in the tulip threads localized to the minor diameter of the second and third threads.Damage was visible on the superior surface and minor diameter radii of the hexalobular drive feature of the screw shank.Bioburden was found in the tulip threads and in the screw shank drive feature as well.During functional evaluation of the screw, the screw head was remobilized according to the procedure outlined in the related surgical technique guide.The previously mentioned deformation prevented the screw from being assembled with a threaded rigid driver.The observed deformation is typically found when attempting to improperly attach a driver to the screw when the screw shank drive feature is inaccessible due to the tulip being locked at an angle relative to the screw shank.The surgical technique guide indicates the screw head should be remobilized when the drive feature of the screw shank is inaccessible.The proper remobilization technique and associated order of operations can be found in the surgical technique guide.However, because the exact surgical conditions during the initial surgery cannot be identified or replicated to determine the initial placement of the screw in relation to the nerve roots which prompted the revision surgery, no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery was done to reposition a creo amp 6.5x45mm modular screw that was touching the nerve root.This event occurred in australia.

• Brand Name: CREO STABILIZATION SYSTEM
• Common Device Name: CREO AMP 6.5X45MM MODULAR 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: 18837604
• Report Number: 3004142400-2023-00115
• Device Sequence Number: 12627097
• Product Code: MNH
• UDI-Device Identifier: 00889095016543
• UDI-Public: 00889095016543
• 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): 03/04/2024

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: 1067.1645
• Device Lot Number: BAT516DD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2016
• 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