PIVOX™ Oblique Lateral Spinal System 2111255Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 2111255 OLIF25 20MM 6 DEG 10X55 · Class 2 · Implant
All models of PIVOX Oblique Lateral Spinal System (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169601475), received between Dec 24, 2019 and Mar 20, 2025 — classified as 1 injury, 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
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2025Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING OLIF (OBLIQUE LATERAL APPROACH FOR LUMBAR SPINE FUSION SURGERY). IT WAS REPORTED THAT THE IMPLANTATION PORT OF PRODUCT HAD A SLIPPERY PHENOMENON, WHICH MADE THE IMPLANTER UNABLE TO COOPERATE WITH THE PROSTHESIS. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21650060 ↗InjuryDec 24, 2019Break; Break
THE REVISION WAS PLANNED BUT THE PATIENT WAS NOT DOING WELL DUE TO HIS OTHER PREVIOUS ILLNESS AND HIS OLD AGE. THE PATIENT RECEIVED DORSAL STABILIZATION. HENCE, THE IMPLANT STILL REMAINS IMPLANTED IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9516862 ↗
Other Intervertebral fusion device with integrated fixation, lumbar devices
- PIVOX™ Oblique Lateral Spinal System 2161001Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, lumbar182 reports
- IdentiTi 232-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall8 reports
- IdentiTi 232-10-85-250Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall5 reports
- IdentiTi 132-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall3 reports
- MectaLIF Anterior 03.30.301Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall2 reports
- IdentiTi 232-10-85-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall2 reports
- IdentiTi 232-11-90-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall1 report
- MectaLIF Anterior 03.30.302Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
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.
How reports and recalls are matched · Editorial policy · Report an error on this page