SPATIAL FRAME 71070365Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556012871), received between Sep 29, 2020 and Jan 13, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING UNSPECIFIED SURGERY, THE ROCKER RING BROKE INSIDE OF THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO DELAY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11162535 ↗
• InjuryDec 16, 2020Break; Break

  IT WAS REPORTED THAT, AFTER AN UNKNOWN PROCEDURE, IT WAS NOTICED THAT THE ROCKER RING BROKE IN THE BACK, AT THE S+N LOGO. PATIENT WAS ADMITTED IN THE CLINIC FOR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023469 ↗
• InjurySep 29, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE ROCKER RING BROKE IN THE MIDDLE OF THE POSTERIOR PORTION. PROCEDURE FINISHED WITH COMPETITOR DEVICE. UNKNOWN IF HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10602765 ↗