Precept 8896540Recalls & reported problems
Nuvasive, Inc. · PRECEPT Screw Shank, 6.5x40mm Modular · Class 2 · Implant
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 00887517387530), received between Sep 12, 2017 and Sep 12, 2017 — 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
- Failure of Implant1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2017Fracture; Fracture
IT WAS REPORTED DURING A ROUTINE FOLLOW UP VISIT IT WAS DISCOVERED VIA X-RAY THAT THE SCREW ON THE LEFT SIDE OF THE S1 LEVEL CONSTRUCT HAD FRACTURED. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2017 WHERE THE BROKEN SCREWS AND RODS WERE REPLACED AND AN ADJACENT LEVEL WAS ADDED TO THE CONSTRUCT AT THE L3 LEVEL. DURING THE PROCEDURE IT WAS OBSERVED THAT THE S1 SCREW HAD FRACTURED ON THE RIGHT SIDE OF THE CONSTRUCT. WHEN ATTEMPTING TO REMOVE THE SCREWS HALF OF THE FRACTURED SCREW COULD NOT BE RETRIEVED FROM THE PATIENT AND WAS LEFT IN BONE. THE SURGEON REPORTED PSEUDARTHROSIS WAS OBSERVED AND BELIEVED MAY HAVE CONTRIBUTED TO THE EVENT. NO ADVERSE ISSUES TO THE PATIENT WERE REPORTED. IT WAS REPORTED THE PATIENT IS DOING WELL POST-REVISION SURGERY.
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 6859696 ↗
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- 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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