AVS UniLIF 48395124Recalls & reported problems
Stryker Corporation · PEEK SPACER · Class 2 · Implant
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 07613252094722), received between Jun 25, 2018 and Jun 25, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Migration1
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant1
- Neuropathy1
- Numbness1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2018Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration; Migration
THE PATIENT REPORTED THAT A CAGE WHICH WAS IMPLANTED ON (B)(6) 2014, HAD SLID OUT FROM L4/L5 AND HE WILL UNDERGO CORRECTIVE SURGERY (B)(6) 2018 DUE TO EXCRUCIATING PAIN. PATIENT REPORTED THE SAME TYPE OF PAIN RADIATING DOWN RIGHT LEG, NEUROPATHY, AND NUMBNESS IN RIGHT FOOT, WHICH GOT WORSE SINCE (B)(6) 2014, WHEN SYMPTOMS STARTED. DEVICE WILL BE REMOVED. IN ADDITION, PATIENT REPORTED THAT X-RAYS SHOW, CAGE MOVED ABOUT 3/4 INCH TOWARD POSTERIOR AND RIGHT AND PHYSICIAN STATED, "IT IS PARTIALLY FUSED IN A BAD PLACE. HE HAS TO CUT IT OUT." PATIENT ADDITIONALLY REPORTED THAT, "THE CT SCANS SHOW HALO AROUND SCREWS WHICH MIGHT INDICATE LOOSENING ACCORDING TO THE PHYSICIAN."
Patient problems: Failure of Implant; Neuropathy; Numbness; Pain
MAUDE report 7635286 ↗
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.
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