RELIANCE IS3048RELRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327142143), received between Jul 11, 2016 and May 2, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2018Fracture; Break; Detachment Of Device Component; Fracture

  IT WAS REPORTED THAT WHILE THE SURGEON WAS PREPPING THE DISC SPACE TO PLACE AN INTER-BODY CAGE, THE 7MM AND 8MM CUSTOM OVAL SHAVERS BROKE IN THE PATIENT. A BACKUP SHAVER WAS USED TO COMPLETE THE PROCEDURE. FRAGMENTS WERE RETRIEVED SUCCESSFULLY. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7479032 ↗
• MalfunctionMay 2, 2018Fracture; Break; Detachment Of Device Component; Fracture

  IT WAS REPORTED THAT WHILE THE SURGEON WAS PREPPING THE DISC SPACE TO PLACE AN INTER-BODY CAGE, THE 7MM AND 8MM CUSTOM OVAL SHAVERS BROKE IN THE PATIENT. A BACKUP SHAVER WAS USED TO COMPLETE THE PROCEDURE. FRAGMENTS WERE RETRIEVED SUCCESSFULLY. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7478960 ↗
• MalfunctionMay 12, 2017Break; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DOCTOR WAS PREPPING THE DISC SPACE WITH THE 7MM OVAL SHAVER, SHAVER BROKE IN THE DISC. FRAGMENT WAS RETRIEVED WITHOUT ADVERSE CONSEQUENCES. THE NEXT SIZE UP SHAVER WAS USED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6565077 ↗
• MalfunctionJul 19, 2016Break; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT; 9MM SHAVER WAS PLACED IN THE DISC SPACE. WHEN TURNED TO REMOVE DISC MATERIAL, THE SHAVER BROKE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5804097 ↗
• MalfunctionJul 11, 2016Break

  IT WAS REPORTED THAT THE DOCTOR WAS PUTTING IN THE PEEK BONE SPACER AND ON THE SECONDARY IMPACT THE BONE CRACKED. WE TOOK AS MUCH OUT AS WE COULD AND PUT ANOTHER SPACER IN. EVERYTHING WENT SUCCESSFULLY AFTER THAT. ADDITIONALLY: THE DOCTOR SAID THE PATIENT WAS AUTO FUSED IN THE L4-5 DISC SPACE BUT STILL WANTED TO GET A SPACE IN THERE. IN DOING SO HE USED THE 7 SHAVER TO BREAK UP THE BONE. THE 7MM SHAVER BROKE AND WAS RETRIEVED SUCCESSFULLY. THE SHAVER WILL BE SENT BACK TO YOU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5784203 ↗