Precept 8801365Recalls & reported problems
Nuvasive, Inc. · PRECEPT Tap, 6.5mm Double Lead Cann · Class 2
All models of Precept (21)
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 00887517354167), received between Sep 7, 2023 and Sep 7, 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 16, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- 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.
MalfunctionSep 7, 2023Fracture; Fracture
ON (B)(6) 2023 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM L4 TO L5. DURING PROCEDURE WHILE TAPPING ON THE RIGHT L5 VERTEBRAE THE DISTAL TIP OF THE DEVICE FRACTURED OFF BUT WAS ABLE TO BE RETRIEVED FROM THE PATIENT. IT WAS REPORTED THE PATIENT LIKELY HAD HARD BONE AND EXCESSIVE OFF ANGLE FORCES WERE UTILIZED, WEAR AND TEAR TO THE DEVICE WAS ALSO OBSERVED. THE SURGERY WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17702010 ↗
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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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