Precept 8805555ARecalls & reported problems

Nuvasive, Inc. · PRECEPT Screw, 5.5x55mm 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 00887517449788), received between Aug 15, 2017 and Aug 15, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Break1

Patient problems

Failure of Implant1

Recent adverse event reports

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

MalfunctionAug 15, 2017Break; Break
RECEIVED INFORMATION STATING PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE ON (B)(6) 2015, WITH UNI LATERAL PRECEPT SCREWS USING MEDTRONIC BONE MORPHOGENETIC PROTEINS TO PACK COROENT CAGES. ON (B)(6) 2017, RADIOGRAPH SHOWED A BROKEN SCREW AT THE L4 MID PEDICLE LEVEL. IT IS UNKNOWN IF PATIENT UNDERWENT A REVISION SURGERY AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 6795511 ↗

Device details

UDI-DI	`00887517449788`
Brand	Precept
Model	8805555A
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.