LineSider LS-TU7S5560Recalls & reported problems

Integrity Implants Inc. · Tulip 5.5/6.0mm Head - 7.1mm Ball - Standard · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818613029055), received between Aug 24, 2020 and Aug 9, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Detachment of Device or Device Component2
Material Separation1

Patient problems

No Clinical Signs, Symptoms or Conditions2
Foreign Body In Patient1
Vertebral Fracture1

Recent adverse event reports

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

InjuryAug 9, 2024Material Separation; Material Separation
ON 12-JUL-2024, ACCELUS WAS MADE AWARE OF AN ISSUE WITH AN IMPANT THAT A TULIP CAME OFF A SHANK CAUSING FAILURE. IT HAD SEPARATED. A REVISION SURGERY WAS NEEDED DUE TO PATHOLOGY / FRACTURE THAT OCCURRED DUE TO HARDWARE FAILURE FROM THE FIRST SURGERY AND IT IS UNKNOWN THE EXACT TIMING OF THAT FAILURE. THE REVISION SURGERY TOOK PLACE APPROXIMATELY 7 WEEKS AFTER THE INITIAL SURGERY (IMPLANT DATE: (B)(6) 2024, EXPLANT DATE: (B)(6) 2024). THE REP REPORTED, "I CANNOT ANSWER IF THE PATIENTS WAS COMPLAINING. I DO NOT KNOW THE ANSWER. I DO NOT KNOW THE OUTCOME OF THE REVISION LONG TERM, BUT THE INFORMATION IS THAT THE REVISION WAS COMPLETED SUCCESSFULLY BUT NOT SURE IF THAT WAS WITH ACCELUS PRODUCT OR NOT." THE FAILED PRODUCT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Vertebral Fracture
MAUDE report 19951030 ↗
InjuryJun 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL POSTERIOR FIXATION PROCEDURE ON (B)(6) 2021. SUBSEQUENTLY, POST-OPERATIVE IMAGES, OBTAINED ON (B)(6) 2021, REVEALED DISSOCIATION OF THE LINESIDER STANDARD TULIP FROM THE SCREW SHANK. A REVISION PROCEDURE WAS CONDUCTED ON (B)(6) 2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11943051 ↗
MalfunctionAug 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT NO SERIOUS INJURY WAS REPORTED AS A RESULT OF THIS PRODUCT MALFUNCTION. ADDITIONALLY, THIS MALFUNCTION HAS NOT PREVIOUSLY BEEN REPORTED TO INTEGRITY IMPLANTS AS HAVING CAUSED OR CONTRIBUTED TO A SERIOUS INJURY ON A SAME/SIMILAR DEVICE IN THE PAST. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.
Patient problems: Foreign Body In Patient
MAUDE report 10444571 ↗

Device details

UDI-DI	`00818613029055`
Brand	LineSider
Model	LS-TU7S5560
Company	Integrity Implants Inc.
Product code	NKB · Thoracolumbosacral Pedicle Screw System
Class	Class 2
FDA submission	K190360
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	Sep 11, 2024

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.

Other Thoracolumbosacral Pedicle Screw System devices

EXPEDIUM VERSE 199721000
Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
387 reports
Sequoia® 3301-1
Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
184 reports
CD HORIZON® Spinal System 8590855
Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
179 reports
Vitality® 07.02011.001
Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
3 recalls0 reports
EXPEDIUM VERSE 199721001S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
124 reports
LineSider LS-N6SA7550
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls1 report
LineSider LS-N6SA6545
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls0 reports
EXPEDIUM VERSE 199721000S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
97 reports

All Thoracolumbosacral Pedicle Screw System 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 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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