ORACLE 03.809.972Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034726908), received between Feb 8, 2017 and Nov 6, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON OCTOBER 25, 2024 DURING USE OF SLAP HAMMER FROM THE CONDUIT TLIF INSTRUMENT SET AN INJURY ON EITHER NERVE ROT OR DURA WAS INFLICTED TO THE PATIENT. IT HAPPENED DURING THE PROCEDURE OF PLACING A CONDUIT TLIF IMPLANT. HAMMER IS NOT PART OF THE REBRANDED CONDUIT TLIF INSTRUMENTATION. THE PREVIOUSLY USED HAMMER WAS NOT IN THE SET. THIS WAS SURGEON DECISION. NO CURRENT PATIENT CONSEQUENCE.

  Patient problems: Nerve Damage

  MAUDE report 20622081 ↗
• MalfunctionMar 2, 2017Break; Break

  IT WAS REPORTED THAT TWO ORACLE SLAP HAMMERS ARE BROKEN INTO TWO PIECES AND ARE WORN OUT. THIS WAS DISCOVERED IN STERILE PROCESSING AFTER THE DEVICES WERE STERILIZED. THE SECOND PIECE OF ONE OF THE SLAP HAMMERS WAS DISCARDED BY THE HOSPITAL. NO ISSUES WITH THE DEVICES PRIOR TO DISCOVERY. NO CASE OR PATIENT INVOLVEMENT. THIS IS REPORT NUMBER 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6371909 ↗
• MalfunctionFeb 8, 2017Break; Break

  IT WAS REPORTED THAT A T-HANDLE T25 STARDRIVE SHAFT WAS STRIPPED AT THE TIP, THE SLEEVE THREADS OF A HOLDING SLEEVE-STANDARD WITH STOP FOR MATRIX WERE STRIPPED, THE TIP OF THE T-PAL TRIAL SPACER HAS BROKEN OFF, THE TIP OF THE T-PAL SPACER APPLICATOR HAS BROKEN OFF, AND THE SLAP HAMMER BROKE INTO (2) PIECES AT THE VERY LOWEST PART OF THE HAMMER. THIS WAS DISCOVERED DURING ROUTINE INSPECTION. THERE IS NO PATIENT OR CASE INVOLVED. THIS IS REPORT 5 OF 5 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6311821 ↗