MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO 5.5 CROSS CONNECTOR, 48-60MM LONG

Model Number	1119.0046
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was available for evaluation.It was reported that metal debris was found when tightening the right side set screw of a cross connector after insertion of screws and rods.The patient was a 76 year old female who was instrumented for an l3-5 posterior lumbar fusion on (b)(6) 2024.The metal piece from the cross connector was discovered during this initial surgery and the debris was reported to be recovered at the time of surgery.Additionally, the cross connector was removed and replaced with a new one during the same procedure and post op imaging confirmed all of the metal debris was recovered.Images of the affected cross connector were provided that showed minor wear to the connector body with a rolled thread start on the male connector.The set screw from the male side of the connector was dissociated from the body exposing the threads.The threads of the set screw were observed to be rounded and partially stripped with a portion of the second thread peeling away from set screw.Visual inspection of the parts found to have consistent wear as featured in the provided images.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a metal piece was found during a surgery.It was removed, and nothing was left in the patient post operatively.This event occurred in japan. .

• Brand Name: CREO
• Common Device Name: CREO 5.5 CROSS CONNECTOR, 48-60MM LONG
• 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: 19165795
• Report Number: 3004142400-2024-00070
• Device Sequence Number: 20691901
• Product Code: MNH
• UDI-Device Identifier: 00889095059564
• UDI-Public: 00889095059564
• 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
• 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): 04/22/2024

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: 1119.0046
• Device Lot Number: HAB192AF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Race: Asian