Precept 8807545ARecalls & reported problems
Nuvasive, Inc. · PRECEPT Screw, 7.5x45mm Polyaxial · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517151216), received between Sep 16, 2020 and Sep 16, 2020 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blood Loss1
- Hematoma1
- Pain1
- Venipuncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
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- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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