Precept 8890000Recalls & reported problems
Nuvasive, Inc. · PRECEPT Tulip, Modular · Class 2 · Implant
All models of Precept (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517385604), received between Jan 8, 2016 and Jun 4, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment Of 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 Component1
- Device Slipped1
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2018Detachment Of Device Component; Detachment Of Device Component
ON (B)(6) 2018 A PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE AT L5-S1 LEVELS WITH NO ISSUES REPORTED. ON (B)(6) 2018 DURING FOLLOW UP RADIOGRAPHS REVEALED A TULIP SEPARATION AT THE S1 RIGHT SIDE LEVEL. ON (B)(6) 2018 A REVISION PROCEDURE WAS COMPLETED WHERE THE SCREW WAS REPLACED WITH NO ADDITIONAL ISSUE REPORTED. NO PATIENT HARM OR INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 7567682 ↗MalfunctionJan 8, 2016Device Slipped; Device Slipped
ON (B)(6) 2015 A (B)(6) MALE PATIENT RECEIVED A REVISION PROCEDURE AS A RESULT OF A PREVIOUSLY IMPLANTED PRECEPT CONSTRUCT MAKING A SQUEAKING SOUND DURING MOVEMENT, WHEN HARDWARE WAS REMOVED THE LEFT L4 SCREW WAS NOTED TO BE LOOSENED AND WORN.
Patient problems: Failure of Implant
MAUDE report 5355985 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 reports
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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