Precept 8808500ARecalls & reported problems

Nuvasive, Inc. · PRECEPT Screw, 8.5x100mm Polyaxial · Class 2 · Implant

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 00887517152220), received between Jul 15, 2022 and Jul 15, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Separation Problem1

Patient problems

Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

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 ↗

Device details

UDI-DI	`00887517152220`
Brand	Precept
Model	8808500A
Company	Nuvasive, Inc.
Product code	NKB · Orthosis, spinal pedicle fixation, for degenerative disc disease
Class	Class 2
FDA submission	K121619
Implant	Yes
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 11, 2025

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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All Orthosis, spinal pedicle fixation, for degenerative disc disease devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.