ReLine 10255212Recalls & reported problems

Nuvasive, Inc. · RSS Iliac Saddle, 5.5mm Ant Ang Ø12 · Class 2 · Implant

All models of ReLine (129)

Data updated Oct 18, 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 00887517985811), received between Dec 27, 2019 and Dec 27, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 18, 2026.

Most reported problems

Device problems

Migration or Expulsion of Device1

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.

MalfunctionDec 27, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2019, A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE WITH NO REPORTED ISSUES. AS PER REPORTER, THE IMPLANT HAS MIGRATED. A REVISION PROCEDURE IS BEING PLANNED BUT HAS NOT BEEN CONDUCTED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 9525691 ↗

Device details

UDI-DI	`00887517985811`
Brand	ReLine
Model	10255212
Company	Nuvasive, Inc.
Product code	KWP · APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Class	Class 2
FDA submission	K182974
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 11, 2025

Device type (GMDN): Bone-screw internal spinal fixation system hook

An implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.

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All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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