Pro Lift 151-261Recalls & reported problems
Life Spine, Inc. · Class 2
Data updated Oct 16, 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 00190837030940), received between May 9, 2019 and May 20, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Improper or Incorrect Procedure or Method1
- Malposition of Device1
Patient problems
- Foreign Body In Patient1
- 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.
MalfunctionMay 20, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
SURGEON PLACED THE IMPLANT AND REMOVED THE INSTALLER, TOOK AN X-RAY AND DETERMINED THAT THE IMPLANT NEEDED TO BE MOVED. HOWEVER COULD NOT ATTACH THE INSTALLER TO THE IMPLANT AFTER ATTEMPTS BOTH VISUALLY AND WITH A MICROSCOPE DETERMINED THAT HE COULD NOT RE-ATTACH. A VASCULAR SURGEON WAS CALLED TO REMOVE THE IMPLANT (REMOVAL PROCESS TOOK 2-HOURS) , A NEW IMPLANT WAS INSTALLED AND SURGERY WAS SUCCESSFUL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8623665 ↗InjuryMay 9, 2019Malposition of Device; Detachment of Device or Device Component
SURGEON WAS IMPLANTING SPINAL CAGE. THE CAGE WAS ADVANCED, X-RAY TAKEN AND SURGEON DETERMINED CAGE WAS ADVANCED TOO FAR, SURGEON ATTEMPTED TO PUT BACK ON CAGE INSERTER, CAGE INSERTER DETACHED FROM CAGE IMPLANT. SURGEON WAS UNSUCCESSFUL IN ATTEMPTS TO RETRIEVE CAGE. VASCULAR SURGEON CONSULTED. CT SCAN COMPLETED. PT RETURNED TO OPERATING ROOM FOR ADD'L SURGERY, VASCULAR SURGEON RETRIEVED CAGE THROUGH AN ABDOMINAL APPROACH. PT WAS EXTUBATED IN OPERATING ROOM. NOTED PT WAS MOVING ALL FOUR EXTREMITIES, PT TRANSPORTED TO PACU FOR RECOVERY. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 8596777 ↗
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- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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