ReLine 16024530Recalls & reported problems

Nuvasive, Inc. · RELINE MAS Red Screw, 4.5x30mm Poly 2C · Class 2 · Implant

All models of ReLine (129)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517555885), received between Sep 2, 2022 and Sep 2, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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, 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

Loosening of Implant Not Related to Bone-Ingrowth3

Patient problems

Osteomyelitis3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjurySep 2, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
(B)(6) 2021, TH3/4/5/6/10/11/12 WERE FIXED WITH RELINE DUE TO INFECTIOUS SPONDYLITIS. ON (B)(6) 2021 A PATIENT UNDERWENT A SPINAL PROCEDURE AT T3/6 AND T10/12 DUE TO INFECTIOUS SPONDYLITIS. ON (B)(6) 2022 A REVISION SURGERY WAS CONDUCTED DUE TO RECURRENCE OF INFECTION AND LOOSENING OF THE PEDICLE SCREWS ON THE LEFT SIDE. THE RODS WERE CUT ON THE CAUDAL SIDE OF TH6. A PEDICLE SCREW WAS ADDED TO THE LEFT TH2, AND THE PEDICLE SCREWS OF TH4, 5, AND 6 WERE INCREASED IN SIZE. A 2-HOLE INLINE CONNECTOR WAS INSTALLED IN TH6 AND CONNECTED TO THE ROD ON THE CAUDAL SIDE. THE ROD ON THE RIGHT SIDE WAS CUT ON THE CAUDAL SIDE OF TH6. A PEDICLE SCREW WAS ADDED TO TH2 AND THE PEDICLE SCREW OF TH4 WAS INCREASED IN SIZE. THE PEDICLE SCREWS OF TH5 AND TH6 WERE NOT REMOVED. A 2-HOLE INLINE CONNECTOR WAS PLACED ON THE CAUDAL SIDE OF TH6 AND CONNECTED TO THE ROD ON THE CAUDAL SIDE. THE SCREW HEAD OF THE 2-HOLE INLINE CONNECTOR ON THE RIGHT SIDE WAS NOT STRIPPED. THE PATIENT'S BONE QUALITY WAS IN VERY POOR CONDITION.
Patient problems: Osteomyelitis
MAUDE report 15351872 ↗
InjurySep 2, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ON (B)(6) 2021, TH3/4/5/6/10/11/12 WERE FIXED WITH RELINE DUE TO INFECTIOUS SPONDYLITIS. ON (B)(6) 2021 A PATIENT UNDERWENT A SPINAL PROCEDURE AT T3/6 AND T10/12 DUE TO INFECTIOUS SPONDYLITIS. ON (B)(6) 2022 A REVISION SURGERY WAS CONDUCTED DUE TO RECURRENCE OF INFECTION AND LOOSENING OF THE PEDICLE SCREWS ON THE LEFT SIDE. THE RODS WERE CUT ON THE CAUDAL SIDE OF TH6. A PEDICLE SCREW WAS ADDED TO THE LEFT TH2, AND THE PEDICLE SCREWS OF TH4, 5, AND 6 WERE INCREASED IN SIZE. A 2-HOLE INLINE CONNECTOR WAS INSTALLED IN TH6 AND CONNECTED TO THE ROD ON THE CAUDAL SIDE. THE ROD ON THE RIGHT SIDE WAS CUT ON THE CAUDAL SIDE OF TH6. A PEDICLE SCREW WAS ADDED TO TH2 AND THE PEDICLE SCREW OF TH4 WAS INCREASED IN SIZE. THE PEDICLE SCREWS OF TH5 AND TH6 WERE NOT REMOVED. A 2-HOLE INLINE CONNECTOR WAS PLACED ON THE CAUDAL SIDE OF TH6 AND CONNECTED TO THE ROD ON THE CAUDAL SIDE. THE SCREW HEAD OF THE 2-HOLE INLINE CONNECTOR ON THE RIGHT SIDE WAS NOT STRIPPED. THE PATIENT'S BONE QUALITY WAS IN VERY POOR CONDITION.
Patient problems: Osteomyelitis
MAUDE report 15351852 ↗
InjurySep 2, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ON (B)(6) 2021, TH3/4/5/6/10/11/12 WERE FIXED WITH RELINE DUE TO INFECTIOUS SPONDYLITIS. ON (B)(6) 2021 A PATIENT UNDERWENT A SPINAL PROCEDURE AT T3/6 AND T10/12 DUE TO INFECTIOUS SPONDYLITIS. ON (B)(6) 2022 A REVISION SURGERY WAS CONDUCTED DUE TO RECURRENCE OF INFECTION AND LOOSENING OF THE PEDICLE SCREWS ON THE LEFT SIDE. THE RODS WERE CUT ON THE CAUDAL SIDE OF TH6. A PEDICLE SCREW WAS ADDED TO THE LEFT TH2, AND THE PEDICLE SCREWS OF TH4, 5, AND 6 WERE INCREASED IN SIZE. A 2-HOLE INLINE CONNECTOR WAS INSTALLED IN TH6 AND CONNECTED TO THE ROD ON THE CAUDAL SIDE. THE ROD ON THE RIGHT SIDE WAS CUT ON THE CAUDAL SIDE OF TH6. A PEDICLE SCREW WAS ADDED TO TH2 AND THE PEDICLE SCREW OF TH4 WAS INCREASED IN SIZE. THE PEDICLE SCREWS OF TH5 AND TH6 WERE NOT REMOVED. A 2-HOLE INLINE CONNECTOR WAS PLACED ON THE CAUDAL SIDE OF TH6 AND CONNECTED TO THE ROD ON THE CAUDAL SIDE. THE SCREW HEAD OF THE 2-HOLE INLINE CONNECTOR ON THE RIGHT SIDE WAS NOT STRIPPED. THE PATIENT'S BONE QUALITY WAS IN VERY POOR CONDITION.
Patient problems: Osteomyelitis
MAUDE report 15351809 ↗

Device details

UDI-DI	`00887517555885`
Brand	ReLine
Model	16024530
Company	Nuvasive, Inc.
Product code	NKB · Orthosis, spinal pedicle fixation, for degenerative disc disease
Class	Class 2
FDA submission	K143684
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 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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