SIGMA 9505-02-144Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295228455), received between Aug 28, 2018 and Jun 16, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  WEAR OF RUBBER SEALS AT THE SHIM ATTACHMENT SITE. RUBBER WEAR PARTICLES CAN POTENTIALLY FALL OUT DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12011280 ↗
• MalfunctionSep 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  RUBBER O-RING AT THE CONNECTION SITE BETWEEN POSITIONER AND SHIM HAS FALLEN OUT DURING CLEANING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10560386 ↗
• MalfunctionApr 3, 2019Break; Contamination /Decontamination Problem; Naturally Worn; Break; Contamination /Decontamination Problem; Naturally Worn

  RUBBER O-RING IN THE HOLES FOR THE SHIM ATTACHMENTS WEAR OFF RUBBER DEBRIS PARTICLES AND IS NOT APPROVED BY THE STERILIZATION UNITS AT THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8481142 ↗
• MalfunctionApr 3, 2019Break; Contamination /Decontamination Problem; Naturally Worn; Break; Contamination /Decontamination Problem; Naturally Worn

  RUBBER O-RING IN THE HOLES FOR THE SHIM ATTACHMENTS WEAR OFF RUBBER DEBRIS PARTICLES AND IS NOT APPROVED BY THE STERILIZATION UNITS AT THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8481138 ↗
• MalfunctionAug 28, 2018Break; Break

  IT WAS REPORTED THAT THE RUBBER O-RING AT THE SHIM-ATTACHMENT HOLES WEARS OFF AND RUBBER PARTS FALL OFF DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7822084 ↗
• MalfunctionAug 28, 2018Break; Break

  IT WAS REPORTED THAT THE RUBBER O-RING AT THE SHIM-ATTACHMENT HOLES WEARS OFF AND RUBBER PARTS FALL OFF DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7822074 ↗
• MalfunctionAug 28, 2018Break; Break

  IT WAS REPORTED THAT THE RUBBER O-RING AT THE SHIM-ATTACHMENT HOLES WEARS OFF AND RUBBER PARTS FALL OFF DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7822018 ↗
• MalfunctionAug 28, 2018Break; Break

  IT WAS REPORTED THAT THE RUBBER O-RING AT THE SHIM-ATTACHMENT HOLES WEARS OFF AND RUBBER PARTS FALL OFF DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7821994 ↗
• MalfunctionAug 28, 2018Break; Break

  IT WAS REPORTED THAT THE RUBBER O-RING AT THE SHIM-ATTACHMENT HOLES WEARS OFF AND RUBBER PARTS FALL OFF DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7821975 ↗
• MalfunctionAug 28, 2018Break; Break

  IT WAS REPORTED THAT THE RUBBER O-RING AT THE SHIM-ATTACHMENT HOLES WEARS OFF AND RUBBER PARTS FALL OFF DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7821964 ↗