MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS STABILIZATION SYSTEM; CREO MIS 6.5MM CANNULATED TAP

Model Number	6134.0065
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery the tip of a creo 6.5mm cannulated tap was broken and left in the patient post operatively near the promontory of the sacral.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 shows the fractured tip.The fracture may have occurred if the tip of the 6.5 mm tap was partially tapped into hard bone and then was redirected in an extreme lateral bending angle; however, an exact cause of the reported issue could not be determined.The following sections have been updated.B4, e1, h2, h6, h10.

• Brand Name: CREO MIS STABILIZATION SYSTEM
• Common Device Name: CREO MIS 6.5MM CANNULATED TAP
• 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: 18837355
• Report Number: 3004142400-2023-00091
• Device Sequence Number: 7458256
• Product Code: LXH
• UDI-Device Identifier: 00889095178135
• UDI-Public: 00889095178135
• 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
• 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): 03/02/2024

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: 6134.0065
• Device Lot Number: TLX055CB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2020
• 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: Male
• Patient Race: Asian