LineSider LS-N6SA7550Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818613027891), received between Apr 11, 2022 and Apr 11, 2022 — classified as 1 injury.

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

2 FDA recall records name this device's identifier.

2 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-0418-2023 · Root cause: Device Design · FDA record ↗

2. 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.

• InjuryApr 11, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  ON 03FEB22 ACCELUS WAS INFORMED OF A COMPLAINT ON A LINESIDER NON-MODULAR STANDARD SCREW. IT WAS ORIGINALLY REPORTED BY THE REP THAT AN INTRAOPERATIVE SCREW HEAD SEPARATION HAD OCCURRED DURING THE PROCEDURE. AT THE TIME, THIS WAS ALL THE INFORMATION THAT WAS AVAILABLE. NEW INFORMATION WAS RECEIVED ON 11MAR22. PER THE COMPLAINT ENTRY FORM RECEIVED ON 11MAR22, THE REPORTED WELD FAILURE OCCURRED DURING A REVISION PROCEDURE. THE INITIAL SURGERY WAS A 4 LEVEL PLIF AND FIXATION PROCEDURE THAT TOOK PLACE ON (B)(6) 2021. DURING A POSTOPERATIVE FOLLOW UP VISIT IT WAS NOTED THAT ONE OF CEPHALAD SCREWS WAS LOOSENING, AS A RESULT, THE SURGEON OPTED TO REVISE THE PROCEDURE. THE REVISION PROCEDURE TOOK PLACE ON (B)(6) 2022. IT WAS NOTED DURING THE REVISION PROCEDURE THAT ONE OF THE CAUDAL SCREWS HAD A SEPARATED TULIP HEAD. IT IS UNKNOWN IF THIS SEPARATION OCCURRED POSTOPERATIVELY OR DURING THE REVISION PROCEDURE. THE PROCEDURE WAS COMPLETED BY REMOVING AND REPLACING THE LOOSE CEPHALAD SCREW AND THE SEPARATED CAUDAL SCREW. THE REPORTED WELD FAILURE RESULTED IN A 10 MINUTE DELAY TO THE REVISION PROCEDURE. NO ADDITIONAL PATIENT HARM WAS REPORTED AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074144 ↗

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-