MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO AMP® 6.5 X 35MM MODULAR CANNULATED SCREW

Model Number	1067.4635
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The devices were returned for evaluation and found the screw head had a damaged saddle that appears to have occurred during screw removal.It was reported that the screws were placed into the spinal canal, which would indicate improper placement of the screw and not any malfunction of the implants.The most likely cause of screws placed too long is improper implant selection.
Event or Problem Description
It was reported that following surgery on (b)(6) 2019, the patient complained of hyperesthesia and numbness of the left leg.Post­ operative ct found two screws on l4-left had been laced into the inners spinal canal.Revision surgery was performed on the same day to extract the screws.

• Brand Name: CREO
• Common Device Name: CREO AMP® 6.5 X 35MM 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: 18828108
• Report Number: 3004142400-2019-00014
• Device Sequence Number: 20816951
• Product Code: MNH
• UDI-Device Identifier: 00889095023664
• UDI-Public: 00889095023664
• 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: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1067.4635
• Device Lot Number: MKV267CD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2018
• 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
• Patient Race: Asian