LIF-PTP 300-150-120Recalls & reported problems
Alphatec Spine, Inc. · SIGMA LIF PTP Retractor, 120mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190376307015), received between Jun 9, 2026 and Jun 9, 2026 — classified as 1 death.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hematoma1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJun 9, 2026Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT A SPINAL PROCEDURE AT L3/4 USING THE LATERAL INTERBODY FUSION PRONE TRANSPOSES (PTP) APPROACH FOR ADJACENT SEGMENT DISEASE ON (B)(6) 2026. NO INTRAOPERATIVE ABNORMALITIES WERE REPORTED, AND THE IMMEDIATE POSTOPERATIVE COURSE WAS INITIALLY STABLE. FOUR DAYS POSTOPERATIVELY, THE PATIENT EXPERIENCED BLEEDING REQUIRING TRANSFUSION, AFTER WHICH THE PATIENT STABILIZED. TWO DAYS LATER, RADIOGRAPHIC IMAGING IDENTIFIED A HEMATOMA NEAR THE SEGMENTAL ARTERY NEAR THE L3/4 LEVEL ON THE LEFT APPROACH SIDE. LATER THAT EVENING, THE PATIENT'S CONDITION DETERIORATED, INCLUDING DEVELOPMENT OF A PSOAS MUSCLE HEMATOMA FOLLOWED BY NON-OCCLUSIVE MESENTERIC ISCHEMIA (NOMI), WHICH WAS TRIGGERED BY HEMORRHAGIC SHOCK. THE PATIENT SUBSEQUENTLY EXPIRED.
Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding
MAUDE report 25451223 ↗
Other RETRACTOR devices
- Endo Paddle Retract 173046Covidien LP · RETRACTOR56 reports
- Omni-Tract® 4040Integra Lifesciences Corporation · RETRACTOR1 recall3 reports
- Omni-Tract® 11275Integra Lifesciences Corporation · RETRACTOR1 recall2 reports
- RadiaLux™ 50-101-1Medtronic Navigation, Inc. · RETRACTOR1 recall2 reports
- CHARNLEY 9620-04-000Depuy International Ltd · RETRACTOR1 recall2 reports
- NA 2176-10-000Depuy (Ireland) · RETRACTOR51 reports
- Fathom MR2-102050Seaspine Orthopedics Corporation · RETRACTOR1 recall1 report
- Omni-Tract® 11303RIntegra Lifesciences Corporation · RETRACTOR1 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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