MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; TRANS-FACET-SCREW INTERNAL SPINAL FIXATION SYSTEM, STERILE

Catalog Number	5119.1737
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The purpose of this investigation is to evaluate the reported issue of: screw loosening post-op.The patient was a 40-year-old female, the construct was l3-s1.There was a separate revision in (b)(6) 2025 where the construct was extended to s1 with 2 side-rod connectors.The 7.5 x 35 mm screws were places in s1 on this date.It was then seen right s1 screw had loosened post-op after patient complained of pain on the right side.The screws were removed on (b)(6) 2026 and replaced with 2 si bone granite screws.The product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.
Event or Problem Description
It was reported that the surgeon did a l3-s1 creo one revision as s1 screws were loose.The plan was to replace screws at s1 and add s2a1 screws then remove set screws and rods from old construct and place a longer rod connecting all screws.The set screws on 5 screws and one side by side rod connector were cold welded and couldn't be removed.A custom head splayer was used and set screws were then easily removed.The 5 screws that were removed were replaced with larger diameter screws.The s1 creo one screws were replaced with si bone granite screws.

• Brand Name: CREO
• Common Device Name: TRANS-FACET-SCREW INTERNAL SPINAL FIXATION SYSTEM, STERILE
• 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: 24643629
• Report Number: 3004142400-2026-00057
• Device Sequence Number: 9842501
• Product Code: MNH
• UDI-Device Identifier: 00889095104660
• UDI-Public: 00889095104660
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5119.1737
• Device Lot Number: BAA238HJ, BAB610EJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female