SpineJack 0909200058Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03760253800495), received between Jul 26, 2022 and Jul 29, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Activation Failure; Activation Failure

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: ACTIVATION FAILURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646533 ↗
• MalfunctionApr 21, 2025Separation Failure; Activation Failure; Separation Failure; Activation Failure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY FAILED TO ACTIVATE AND SEPARATE. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876247 ↗
• InjuryApr 7, 2025Use of Device Problem; Activation Failure; Migration; Use of Device Problem; Activation Failure; Migration

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21786551 ↗
• MalfunctionOct 18, 2024Separation Failure; Activation Failure; Separation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A BIPEDICULAR IMPLANT PROCEDURE AT T12, ONE OF THE SPINEJACK IMPLANTS EXPERIENCED A LOT OF PRESSURE DUE TO HARD BONE AND WOULD NOT EXPAND. ADDITIONALLY, THE SAME IMPLANT WOULD NOT RELEASE FROM THE RELEASE PIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A UNIPEDICULAR CASE WITH ONLY CEMENT INJECTED ON ONE SIDE. NO DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20480511 ↗
• MalfunctionJun 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A 2-LEVEL BIPEDICULAR PROCEDURE AT T11 AND T12 IN A PATIENT WITH SOFT BONE AND CANCER, THE OPERATOR NOTED A CHANGE IN THE INFERIOR ENDPLATE OF THE T10 LEVEL AFTER EXPANSION OF THE SPINEJACK IMPLANTS. THE CHANGE WAS DESCRIBED AS "PUSHED IN A LITTLE." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19569755 ↗
• MalfunctionMay 24, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A BIPEDICULAR IMPLANT PROCEDURE THE EXPANSION ASSEMBLY ON ONE SIDE SEEMED TO ADVANCE FURTHER THAN EXPECTED WITHIN THE ACCESS CANNULA, PRESENTING THE POTENTIAL FOR THE IMPLANT TO ALSO REACH AN EXCESSIVE DEPTH WITHIN THE VERTEBRAL BODY. THERE WAS NO REPORT OF THE IMPLANT ACTUALLY REACHING AN EXCESSIVE DEPTH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY-SIGNIFICANT DELAY AND NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16993811 ↗
• MalfunctionJul 26, 2022Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15107756 ↗