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

Model Number	588.026
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had multiple levels of sp fix plates and barrels placed.The top level which was a double tab locking plate which became separated from the barrel.
Additional Manufacturer Narrative
No part was received, so no physical evaluation could be conducted.No adverse effects to the patient were noted based on the event evaluation form (attached).No dhr evaluation could be completed because no lot number information was provided.A call with the rep revealed the issue was identified post-operatively.The rep was not present for the case.X-ray images were requested, but none were received.No information was available regarding which levels sp-fix implants had been used on.It was known that there were multiple levels of sp-fix plates and barrels placed.This is an off-label use and could have contributed to the failure.The surgeon took out the sp-fix plates and put medtronic pedicle screws in instead.The rep suggested an error could have arisen from the surgeon adjusting the multiple implants in-situ.The most likely cause from the information provided is improper implant placement as post-op trauma is unlikely.This complaint will be reopened for further investigation if more information is received.This evaluation determined that this failure was within the expected risk profile; therefore, no further actions will be taken at this time.
Event or Problem Description
It was reported that a patient had multiple levels of sp fix plates and barrels placed.The top level which was a double tab locking plate which became separated from the barrel.
Additional Manufacturer Narrative
All parts noted in the complaint were received.An image has been uploaded to the jira ticket.Visual evaluation of the components revealed two barrels in the unlocked position and one in the locked position along with its respective pivoting plate.All components show wear that is consistent with normal usage and operation.The tip of each ratcheting rod has been cut off, with marks consistent from the ratcheting rod cutter, provided in the instrument set.This aligns with proper technique is not unusual.Dhr files for all lot numbers and parts were obtained and evaluated.No deviations to processing and no ncr's were found.A search of the capa and scar records did not reference this product family.All materials used met specifications.All drawings were reviewed and were found to be accurate.All lots appear to have been manufactured as intended.It was known that there were multiple levels of sp-fix plates and barrels placed during the index level surgery.This is an off-label use and could have contributed to the failure.The cause cannot be established at this time.No further actions will be taken at this time.This complaint will be reopened for further investigation if more information is received.The following sections were updated for this supplemental report: b4, d4, d9, g3, g6, h2, h3, h10.

• Brand Name: SP-FIX
• 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: 23608426
• Report Number: 3004142400-2025-00279
• Device Sequence Number: 18454033
• Product Code: KWP
• UDI-Device Identifier: 00849044092257
• UDI-Public: 00849044092257
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 03/02/2025

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 Model Number: 588.026
• Device Lot Number: AXC347AD, AXC635TD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown