GoPLF! Posterior Lateral Fusion System 4010001Recalls & reported problems
GetSet Surgical SA · The GoPLF! Core instrument set contains instruments numbered 1 – 9 that are placed in chronological order within the tray, for an efficient surgical procedure of the GoPLF! Posterior Lateral Fusion Device (system-specific instruments) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640387660829), received between Nov 14, 2025 and Nov 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2025Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method
FROM THE INFORMATION PROVIDED BY THE SURGEON A PATIENT WAS ADMITTED FOR A PLANNED SURGERY TO FIXATE THE ADJACENT LEVEL TO A CONSTRUCT OF GETSET SURGICAL'S IMPLANTS INSERTED 1.5 YEARS PRIOR (FUSION WAS ACHIEVED L5/S1). THE SURGEON INTENDED TO EXTEND THE CONSTRUCT BY REMOVING THE CURRENT ROD. THIS REQUIRED REMOVAL OF THE SET-SCREW. THE BREAK AWAY TIP ON THE T25 DRIVER BROKE DURING THE REMOVAL OF THE SET-SCREW. THE TIP OF THE DRIVER BROKE CLEANLY AND THE ENTIRETY OF THE TIP WAS SUCCESSFULLY RETRIEVED WITH < 5 MINUTE DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23561239 ↗
Other Thoracolumbosacral Pedicle Screw System devices
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- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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