PIVOX™ Oblique Lateral Spinal System 2111355Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 2111355 OLIF25 20MM 6 DEG 12X55 · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169601529), received between Dec 24, 2019 and Dec 24, 2019 — classified as 1 injury.
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 9516878 ↗
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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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