MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; HEAD REMOVAL TOOL

Model Number	6134.1005
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor any imaging was available for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported by a representative in (b)(6) that the instrument broke, and the broken piece remains in the patient.A revision surgery is planned.
Additional Manufacturer Narrative
The fractured tip of the device was not available as it remains in the patient.Inspection of the device shows a small section of the distal tip to have fractured.The exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported by a representative in japan that the instrument broke, and the broken piece remains in the patient.A revision surgery is planned.

• Brand Name: CREO
• Common Device Name: HEAD REMOVAL TOOL
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11765457
• Report Number: 3004142400-2021-00083
• Device Sequence Number: 14383854
• Product Code: LXH
• UDI-Device Identifier: 00889095178388
• UDI-Public: 00889095178388
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 6134.1005
• Device Lot Number: HAX022DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR