PreceptRecalls & reported problems across all models
Nuvasive, Inc. · 21 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 21 models of Precept by Nuvasive, Inc. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2015 and Apr 23, 2026 — classified as 4 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Fracture” (17 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Precept problems
Device problems
- Fracture17
- Unintended Movement12
- Detachment Of Device Component10
- Mechanical Problem4
- Break3
- Adverse Event Without Identified Device or Use Problem2
- Detachment of Device or Device Component2
- Device Slipped2
Patient problems
- Failure of Implant28
- Foreign Body In Patient11
- Pain4
- No Consequences Or Impact To Patient3
- Blood Loss1
- Fall1
- Hematoma1
- No Clinical Signs, Symptoms or Conditions1
Precept models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Precept 8800000APPLIANCE, FIXATION, SPINAL INTERLAMINAL13 reports
- Precept 8801069ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- Precept 8806545AORTHOSIS, SPINAL PEDICLE FIXATION6 reports
- Precept 8890000ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- Precept 8807545AOrthosis, spinal pedicle fixation, for degenerative disc disease1 report
- Precept 8808500AOrthosis, spinal pedicle fixation, for degenerative disc disease1 report
- Precept 8801215STIMULATOR, NERVE1 report
- Precept 8801355STIMULATOR, NERVE1 report
- Precept 8801365STIMULATOR, NERVE1 report
- Precept 8845500APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Precept 8847045Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- Precept 8847065Orthosis, spondylolisthesis spinal fixation1 report
- Precept 8847150Orthosis, spondylolisthesis spinal fixation1 report
- Precept 8848230ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Precept 8896540ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Precept 8896545Orthosis, spondylolisthesis spinal fixation1 report
- Precept 8896550APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Precept 8805545AAPPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Precept 8805555AOrthosis, spinal pedicle fixation, for degenerative disc disease1 report
- Precept 8806550AOrthosis, spinal pedicle fixation, for degenerative disc disease1 report
- Precept 8806555AORTHOSIS, SPINAL PEDICLE FIXATION1 report
Recent Precept adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 23, 2026Fracture
IT WAS REPORTED THAT WHEN THE SURGEON INSERTED SCREW AT S2AI, THE SCREW WAS DEVIATED ALTHOUGH THE GUIDE WIRE USED. HE TRIED REMOVE THE SCREW, BUT THE GUIDE WIRE FRACTURED. THE FRAGMENT OF THE WIRE REMAINED INTO THE BODY AND BLEEDING OCCURRED. THE SURGEON INTERRUPTED SURGERY AND TRANSFERRED THE PATIENT TO THE ANGIOGRAPHY ROOM. AFTER THAT, THE PLANED SURGERY WAS CANCELED. A REVISION SURGERY OCCURRED ON (B)(6) 2026. THE SURGEON REMOVED THE FRAGMENT OF THE WIRE AND COMPLETED SPINAL FIXATION. THE FRAGMENT OF WIRE REMOVED WAS DISCARDED. NO ADVERSE EFFECT REPORTED FOLLOWING THE REVISION.
Patient problems: Foreign Body In Patient
MAUDE report 24966609 ↗MalfunctionSep 23, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A PRECEPT K-WIRE BROKE OFF AND WAS LEFT IN THE BONE OF THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23121674 ↗MalfunctionJun 11, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM L4 TO S1. DURING THE PROCEDURE, A KIRSCHNER WIRE (K-WIRE) WAS INSERTED INTO THE LEFT S1 AND WAS BENT DURING THE PLACEMENT OF THE PEDICLE SCREW OVER THE WIRE. SUBSEQUENTLY, THE DISTAL TIP OF THE K-WIRE FRACTURED WITHIN THE VERTEBRAL BODY AND WAS UNABLE TO BE REMOVED. AS A RESULT, THE TIP WAS RETAINED IN THE PATIENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 19515819 ↗MalfunctionOct 30, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A THREE (3) LEVEL EXTREME LATERAL INTERBODY FUSION PROCEDURE WITH POSTERIOR FIXATION FROM L2 TO L5. DURING THE PROCEDURE, A KIRSCHNER WIRE (K-WIRE) WAS INSERTED INTO L2 AND THE PEDICLE SCREW WAS INSERTED OVER THE WIRE. SUBSEQUENTLY, THE K-WIRE WAS ATTEMPTED TO BE REMOVED WHEN IT WAS NOTED TO BE CAUGHT ON THE TIP OF THE PEDICLE SCREW. DURING SEVERAL ATTEMPTS TO REMOVE THE K-WIRE, THE DISTAL TIP FRACTURED WITHIN THE VERTEBRAL BODY AND WAS UNABLE TO BE REMOVED. AS A RESULT, THE TIP WAS RETAINED IN THE PATIENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 18031708 ↗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 ↗MalfunctionJun 14, 2023Fracture; Fracture
MalfunctionMay 10, 2023Fracture; Fracture
MalfunctionMar 15, 2023Fracture; Fracture
ON FEBRUARY 28TH 2023 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM L3 TO L5. DURING THE PROCEDURE WHILE TAPPING THE RIGHT VERTEBRAL BODY AT L3 THE TIP OF THE TAP FRACTURED OFF FLUSH INTO THE BONE. THE SURGEON DETERMINED THIS WAS NOT A RISK TO THE PATIENT AND LEFT THE FRACTURED PORTION IN SITU. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE DEVICE FAILURE AND THE SURGERY WAS COMPLETED WITHOUT ISSUE.
Patient problems: Foreign Body In Patient
MAUDE report 16542680 ↗MalfunctionJan 10, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL THREE (3) LEVEL POSTERIOR FIXATION PROCEDURE FROM L2 TO L5. DURING THE PROCEDURE, UPON REMOVAL OF THE KIRSCHNER WIRE (K-WIRE) FROM THE RIGHT L3 VERTEBRAE, IT WAS NOTED THAT THE DISTAL TIP HAD FRACTURED OFF AND APPROXIMATELY ONE (1) CM REMAINED WITHIN THE VERTEBRAL BODY. THE FRACTURED PORTION WAS UNABLE TO BE RETRIEVED. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16133900 ↗MalfunctionNov 17, 2022Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL THREE (3) LEVEL POSTERIOR FIXATION PROCEDURE FROM L2 TO L5. DURING THE PROCEDURE, A KIRSCHNER WIRE (K-WIRE) WAS PLACED IN THE PEDICLE BONE AT L3 TO FACILITATE INSERTION OF THE PEDICLE SCREW. SUBSEQUENTLY, THE DISTAL TIP OF THE K-WIRE FRACTURED OFF UPON REMOVAL AND WAS UNABLE TO BE RETRIEVED. AS A RESULT, THE TIP WAS RETAINED IN THE PATIENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 15821087 ↗MalfunctionOct 29, 2022Fracture; Fracture
WHILE INSERTING A PEDICLE SCREW INTO L5, THE TIP OF THE SCREWDRIVER WAS BROKEN OFF IN THE SCREW HEAD. THE FRACTURED TIP COULD NOT BE RETRIEVED AND AS A RESULT THE TIP WAS RETAINED IN THE PATIENT. NO PATIENT HARM WAS REPORTED AS A RESULT OF THE REPORTED EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 15695148 ↗MalfunctionJul 15, 2022Separation Problem; Separation Problem
ON (B)(6) 2021 A POSTERIOR LUMBAR INTERBODY FUSION AND POSTERIOR FIXATION WAS PERFORMED AT L2/S2/ILIUM. ON (B)(6) 2022 A REVISION SURGERY WAS CONDUCTED DUE TO REPLACE THE TULIP SEPARATION AT S2/ILIUM AND LOOSE SCREWS AT L5 AND S1.
Patient problems: Pain
MAUDE report 15033062 ↗MalfunctionMar 31, 2021Fracture; Fracture
A 1. 5MM PIECE OF K-WIRE BROKE OFF IN PATIENT'S SACRUM DURING A SPINAL CASE. SURGEON WAS ATTEMPTING TO DRILL K-WIRE INTO SACRUM.
Patient problems: Foreign Body In Patient
MAUDE report 11595856 ↗InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2019 PATIENT UNDERWENT SPINAL PROCEDURE ON L3-S1 LEVELS. ON (B)(6) 2019, PATIENT WAS EXPERIENCING LEFT SIDED ABDOMINAL PAIN AND DEVELOPED HYPOTENSION. AS PER REPORTER PATIENT WAS FOUND TO BE ANEMIC AND A CT SCAN REVEALED A LEFT RETROPERITONEAL HEMATOMA AND ACTIVE BLEEDING LEFT RETROPERITONEUM. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE EXPLORATION OF LEFT RETROPERITONEUM WITH LIGATION OF BLEEDING VESSEL WAS CONDUCTED.
Patient problems: Blood Loss; Hematoma; Pain; Venipuncture
MAUDE report 10538960 ↗MalfunctionMar 5, 2020Migration or Expulsion of Device; Migration or Expulsion of Device
ON AN UNKNOWN DATE A PATIENT UNDERWENT A SINGLE LEVEL POSTERIOR FIXATION PROCEDURE WITH NO REPORTED ISSUES. POST-OPERATIVE, A SET SCREW WAS IDENTIFIED AS DETACHED. ON (B)(6) 2020 A REVISION PROCEDURE TOOK PLACE. NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 9794715 ↗
Other Nuvasive, Inc. products
All Nuvasive, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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