SIGMA LCS 9505-01-207Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295225157), received between May 16, 2019 and Jun 1, 2026 — classified as 8 malfunctions.

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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Material Deformation

  IT WAS REPORTED THAT THE SHIM DEVICES WERE BROKEN, THE ALIGNMENT ROD WAS BENT AND THE TRIAL POST DEVICES WERE CRACKED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED. THERE WAS NO PATIENT OR USER HARM. THERE WERE NO REPORTS OF SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351297 ↗
• MalfunctionMay 7, 2026Material Deformation

  IT WAS REPORTED THAT THERE WERE BROKEN TRIAL SHIMS, BENT ALIGNMENT ROD, CRACKED TRIAL POST.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110626 ↗
• MalfunctionDec 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRIOR TO THE START OF SURGERY, THE ROD HAD BENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715734 ↗
• MalfunctionApr 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ROD WHICH IS 2 PARTS, HAS 1 LOST PART. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920143 ↗
• MalfunctionOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ITEM WAS MISSING THE SECONDARY COMPONENT. THIS WAS IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441929 ↗
• MalfunctionOct 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PART OF THE ALIGNMENT ROD IS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579794 ↗
• MalfunctionMay 16, 2019Material Twisted/Bent; Material Twisted/Bent

  INSTRUMENT WAS REPORTED TO HAVE BEEN BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8616656 ↗
• MalfunctionMay 16, 2019Material Twisted/Bent; Material Twisted/Bent

  INSTRUMENT WAS REPORTED TO HAVE BEEN BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615984 ↗