MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; CREO THREADED 6.5X40MM REDUCTION SCREW

Model Number	5119.6640
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was done to remove a creo threaded screw that had broken post operatively.This event occurred in (b)(6).
Additional Manufacturer Narrative
A post-operative image of the hardware showed that the screw head dissociated from the screw shank as well as the two clamp halves.No post-operative imaging was available and the part was not returned for further evaluation.The exact cause of the reported issue could not be determined.

• Brand Name: CREO STABILIZATION SYSTEM
• Common Device Name: CREO THREADED 6.5X40MM REDUCTION 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 ; 6109301822
• MDR Report Key: 12683117
• Report Number: 3004142400-2021-00203
• Device Sequence Number: 3342904
• Product Code: MNH
• UDI-Device Identifier: 00889095120578
• UDI-Public: 00889095120578
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D201515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 10/18/2021

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: 5119.6640
• Device Lot Number: JNW232NJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2019
• 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