LineSider LS-N6SG6550Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818613022674), received between Feb 18, 2022 and Feb 18, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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-0419-2023 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionFeb 18, 2022Fracture; Fracture

  ON 27JAN2022 ACCELUS WAS INFORMED OF A POST OPERATIVE FAILURE ON A NON-MODULAR STANDARD SCREW. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2021. DURING A 6 WEEK FOLLOW UP VISIT IT WAS CONFIRMED BY X-RAY IMAGING THAT ONE OF THE TULIPS WAS DISSOCIATED FROM THE SCREW SHANK. ACCELUS WAS ADVISED THAT THE SCREW HEAD APPEARS IN IMAGING TO HAVE BROKEN AT THE POINT WHERE IT ATTACHES TO THE SHAFT (OR TULIP WAS DISSOCIATED FROM THE SCREW) AND THIS MAY BE CONSISTENT WITH A POTENTIAL WELD FAILURE THOUGH INVESTIGATION IS STILL UNDERWAY. THE PATIENT IS CURRENTLY ASYMPTOMATIC, AT THIS TIME THERE ARE NO PLANS TO PERFORM A REVISION SURGERY. THE SURGEON INTENDS TO MONITOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559965 ↗

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-0420-2023 · Jan 27, 2022 · Terminated
  LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-
• 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