Presidio Anterior Lumbar Fixation System 125-603Recalls & reported problems
Life Spine, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190837043247), received between Jun 23, 2020 and Apr 1, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2026Fracture
IT WAS STATED THAT, "BROKE DURING A CASE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756115 ↗MalfunctionMar 5, 2026Fracture
IT WAS STATED, "IT BROKE IN THE VERTEBRAL BODY WHILE BEING INSERTED TO MAKE THE PILOT HOLE FOR THE SCREW. YES THE BROKEN PIECE WAS REMOVED BY HEAVY NEEDLE DRIVER"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24519494 ↗InjuryJun 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THA THE TIP OF THE AWL BROKE OFF DURING THE PROCEDURE BECAUSE OF HARD BONE AND A STEEP ANGLE. THE DOCTOR FELT IT WAS BEST TO LEAVE THE BROKEN PIECE IN THE THAT POSITION AND SAFELY BURIED COMPLETELY IN THE VERTEBRAL BONE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10186626 ↗
Other Appliance, fixation, spinal intervertebral body devices
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- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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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