MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; TOWER REDUCER, THREADED

Model Number	6120.2000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reduction instrument was returned still locked on the implant.The instrument was jammed onto an implant and the threaded knob would not spin when torque was applied by hand.The instrument was able to be unjammed by applying toque with the use of a tower reducer attachment piece and a 1/4" ratcheting t-handle.Once unjammed and the implant was removed from the distal tip, the instrument moved through its normal range of motion without issue.Observation of the device revealed that two of the four male reduction features have been damaged.This damage is consistent with improper seating/alignment of the instrument to the screw head prior to reduction.This would result in the instrument to jam during reduction.The implant shows the similar damage to the reduction features on the screw head.However, an exact cause of the reported issue cannot be determined.
Event or Problem Description
It was reported that during reduction, the tower reducer would not release the screw head leading to the pedicle of the spine breaking out from the body laterally.

• Brand Name: CREO STABILIZATION SYSTEM
• Common Device Name: TOWER REDUCER, THREADED
• 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: 12760270
• Report Number: 3004142400-2021-00209
• Device Sequence Number: 3607785
• Product Code: LXH
• UDI-Device Identifier: 00889095173352
• UDI-Public: 00889095173352
• 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
• 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): 10/25/2021

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
• Operator of Device: Health Professional
• Device Model Number: 6120.2000
• Device Lot Number: TIX232AC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown