LineSider LS-N6MG7545Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818613026542), received between Apr 7, 2021 and Mar 2, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K203367); they may or may not involve this specific model.

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.

Recalls naming this device

1. Jan 27, 2022Terminated

   Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.

   Z-0420-2023 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2022Fracture; Fracture

  ON (B)(6) 2022 ACCELUS WAS INFORMED OF A FAILURE ON A NON-MODULAR MIS TULIP SCREW (PART: LS-N6MG7545). THE SURGEON AT THE SPECIALTY HOSPITAL OF SHREVEPORT WAS PERFORMING A TWO LEVEL ALIF AND FIXATION PROCEDURE ON (B)(6) 2022. THE FAILURE WAS NOTED BY THE SURGEON'S PA WHILE THEY WERE REVIEWING POSTOP FILMS PRIOR TO DISCHARGING THE PATIENT. FURTHER DISCUSSION WITH THE SURGEON CONFIRMED THAT THE FAILURE OCCURRED INTRAOPERATIVELY AND WENT UNNOTICED AT THE TIME OF THE PROCEDURE. FILM IMAGES CONFIRMED A SCREW HEAD SEPARATION AT THE L4 SEGMENT. THE PATIENT WAS NOT DISCHARGED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REMOVE AND REPLACE THE IMPACTED SCREW. THE PATIENT IS REPORTEDLY DOING FINE WITH NO FURTHER ISSUES OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656845 ↗
• InjuryApr 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TWO-LEVEL FIXATION PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED THREE DAYS LATER DUE TO DISSOCIATION OF THE SET SCREW FROM THE PEDICLE SCREW ASSEMBLY. DURING THE REVISION PROCEDURE, AS THE SURGEON ATTEMPTED TO PLACE A NEW SET SCREW, IT WAS IDENTIFIED THAT THE THREADS ON THE TULIP OF THE ASSEMBLY WERE DAMAGED. AS A RESULT, HE OPTED TO REVISE THE ENTIRE PEDICLE SCREW CONSTRUCT ALONG THE IPSILATERAL SIDE. THE NEW ASSEMBLIES AND SET SCREWS WERE PLACED WITH NO ISSUE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627587 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203367. One submission often covers many models, so check the product and lot details in each record.

• Z-0421-2023 · Aug 3, 2022 · Terminated
  LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral pedicle screw system; Spinal i
• Z-0419-2023 · Jan 27, 2022 · Terminated
  LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as
• Z-0418-2023 · Jan 27, 2022 · Terminated
  LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sol