XLR 6900160Recalls & reported problems
Nuvasive, Inc. · XLR Inserter, Implant · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517383532), received between Jan 6, 2023 and Jan 6, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Physical Resistance/Sticking1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
MEDWATCH REPORT # 2031966 - 2023 - 00001 WAS INADVERTENTLY SUBMITTED. AFTER A REVIEW OF THE REPORTED EVENT AND ADDITIONAL INFORMATION RECEIVED, IT HAS BEEN DETERMINED THAT THERE NO INDICATION OF AN ADVERSE REACTION, DEATH OR SERIOUS INJURY, OR THE NEED FOR INTERVENTION TO PREVENT DEATH OR SERIOUS INJURY. FURTHER, DEATH OR SERIOUS INJURY IS UNLIKELY SHOULD THIS OR A SIMILAR EVENT RECUR AND UNRETRIEVED FRAGMENT WAS LEFT IN THE PATIENT. NO REPORTING IS REQUIRED
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16118212 ↗
Other Intervertebral fusion device with integrated fixation, lumbar devices
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- 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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