LUCENT 10010-000Recalls & reported problems
Spinal Elements, Inc. · 10MM INSERTER · Class 1
Data updated Oct 16, 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 00840606122061), received between Dec 4, 2019 and Dec 4, 2019 — 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 16, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2019Fracture; Fracture
DURING A TRANSFORAMINAL LUMBER INTERBODY FUSION (TLIF) SURGERY, ONE OF THE DISTAL PRONGS OF THE INTERBODY INSERTER FRACTURED WHILE INSERTING THE PEEK INTERBODY CAGE. THE PEEK CAGE WAS SUCCESSFULLY PLACED BUT THE INSERTER FRAGMENT REMAINED. THE SURGEON ELECTED TO LEAVE THE FRAGMENT IN-SITU. NO PATIENT INJURY WAS REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9413699 ↗
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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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