NA 03.809.921Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034726700), received between Dec 5, 2019 and Apr 6, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2021Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE ORACLE LATERAL QUICK INSERTER/DISTRACTOR (SQUID) DO NOT ROTATES FREELY AFTER THE CASE. WE PLACED TWO ORACLE INTERBODY CAGES AND EVERYTHING WAS WORKING FINE. DURING ANOTHER INSPECTION SQUID PREPARING FOR A CASE, THE INSERTER THAT ENGAGES WITH THE GRAFT NO LONGER SPINS FREELY ON THE DRIVER. SO IF THE SQUID HANDLE IS TURNED, THE INSERTER ALSO SPINS AND GETS CAUGHT ON THE ARMS OF THE SQUID. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LATERAL QUICK INSERTER/DISTRACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624305 ↗
• MalfunctionFeb 7, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A LATERAL L3-L5 INTERBODY SPINAL FUSION PROCEDURE WITH THE MTF ALLOGRAFT ORACLE SPACER ON (B)(6) 2020, A LATERAL QUICK INSERTER/DISTRACTOR BECAME JAMMED AND DID NOT MOVE AFTER SUCCESSFULLY PLACING THE FIRST SPACER ON AN UNKNOWN LEVEL. THE SURGEON REPORTED THAT SOMETHING WAS FROZEN AS YOU TURN THE HANDLE, CAUSING THE PUSHER PART TO STICK. THE SURGEON USED ANOTHER IMPLANT HOLDER FOR ORACLE CAGE FOR THE SECOND LEVEL. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN ORACLE SPACER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) LATERAL QUICK INSERTER/DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9683249 ↗
• MalfunctionDec 25, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING EVALUATION AT LOANER DEPARTMENT, IT WAS FOUND OUT THAT THE LATERAL QUICK INSERTER DISTRACTOR HAS A BROKEN GUIDE BAR. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9517748 ↗
• MalfunctionDec 5, 2019Mechanical Jam; Mechanical Jam

  DIRECT LATERAL INTERBODY FUSION, (B)(6) 2019. PATIENT ANATOMY PROVED CHALLENGING TO PERFORM DISCECTOMY AND SUBSEQUENTLY SURGEON REPORTED DIFFICULTY INSERTING THE ORACLE QUICK INSERTER DISTRACTOR. THE SURGEON PRECEDED TO USE THE DEVICE OFF LABEL BY USING A MALLET TO IMPACT THE DEVICE INTO THE DISC SPACE. AS THE DEVICE WAS BEING USED TO INSERT CAGE IT BECAME PROGRESSIVELY MORE DIFFICULT TO ROTATE THE INSERTER HANDLE UNTIL THE SURGEON WAS UNABLE TO ROTATE THE HANDLE EITHER IN OR OUT. THE CAGE HAD BEEN INSERTED AS IMAGED USING FLUOROSCOPY. THE SURGEON THEN, USING A MALLET, REMOVED THE DEVICE. THIS ACTION OF REMOVING THE DEVICE ALSO PARTLY EXPLANTED THE ORACLE CAGE. THE CAGE WAS REPOSITIONED USING THE ORACLE IMPACTOR (03.809.881) UPON INSPECTION AFTER THE CASE JNJ REPRESENTATIVE OBSERVED THE PUSHER COMPONENT TO NOT MOVE AS DESIGNED AND PREVENTED THE HANDLE FROM ROTATING, RENDERING THE DEVICE UNSERVICEABLE. 10 MINUTE DELAY TO THE PROCEDURE. PATIENT OUTCOME POST SURGERY: NIL ADVERSE OUTCOMES REPORTED. MALE PATIENT INITIALS M.A.; AGED (B)(6) YEARS; DOB (B)(6) 1937. CONCOMITANT DEVICES REPORTED: UNKNOWN IMPACTION INSTRUMENTS: HAMMER/MALLET: SPINE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) O

  Patient problems: No Code Available

  MAUDE report 9416799 ↗