MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS; TAPS, BONE

Model Number	6134.0075
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during tapping for the screw the tip of the tap broke and remained in the patient.
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Additional Manufacturer Narrative
Visual inspection of the imaging supports the reported issue that the tip of the 7.5mm cannulated tap fractured.Based on the imaging and information provided, a posterior spinal fusion procedure from l3-pelvis was completed on (b)(6) 2025.During the surgery, the distal tip of the 7.5mm cannulated tap fractured in the patient when tapping for the left s2ai screw.The fractured piece of the tap was left in the patient.The part was not returned for evaluation.Due to the inability to investigate the instrument or replicate surgical conditions, the exact cause of the failure cannot be determined.The calculated observed risk level matches the expected risk level; therefore, the overall risk of the system has been maintained and there is no further investigation required.The following sections were updated for this supplemental report: b4, d2, g6, h2, h6, h10.
Event or Problem Description
It was reported that during tapping for the screw the tip of the tap broke and remained in the patient.

• Brand Name: CREO MIS
• Common Device Name: TAPS, BONE
• 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: 23360333
• Report Number: 3004142400-2025-00258
• Device Sequence Number: 8964572
• Product Code: LXH
• UDI-Device Identifier: 00889095178142
• UDI-Public: 00889095178142
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 6134.0075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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