MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CROSS CONNECTOR DRIVER, TORQUE-LIMITING

Model Number	6067.1050
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the tip of the cross connector driver broke and had to be removed by cutting through implants.This event occurred in japan. .
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.Initial observation showed the tip of the device was fractured off.This fracture is consistent with high/excessive forces placed on the tip during removal; however, no determinations could be made as to the cause of the reported issue.

• Brand Name: CREO
• Common Device Name: CROSS CONNECTOR DRIVER, TORQUE-LIMITING
• 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: 18837944
• Report Number: 3004142400-2023-00146
• Device Sequence Number: 7140878
• Product Code: LXH
• UDI-Device Identifier: 00889095168273
• UDI-Public: 00889095168273
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• 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: 6067.1050
• Device Lot Number: BRW199XC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2019
• 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