SpineJack 0909200050Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03760253800471), received between Oct 20, 2022 and Oct 28, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DIFFICULT OR DELAYED SEPARATION. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399811 ↗
• MalfunctionJul 24, 2025Separation Failure; Activation Failure; Separation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587122 ↗
• InjuryJun 9, 2025Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BIPEDICULAR SPINEJACK PLACEMENT AT L2 FOLLOWING A TUMOR ABLATION, ONE OF THE IMPLANTS WOULD NOT RELEASE FROM THE RELEASE ROD. THE SURGEON INITIALLY ATTEMPTED TO OBTAIN A STRONGER GRIP ON THE RELEASE ROD BY USING A HEMOSTAT OR KOCHER, AS WELL AS VISE GRIPS, AND THEN MALLETING UP FROM UNDERNEATH; THE BLUE HANDLE OF THE RELEASE ROD CAME OFF. THE SURGEON THEN INJECTED CEMENT TO STABILIZE THE SYSTEM. AFTER THE CEMENT HAD HARDENED, RELEASE WAS ATTEMPTED AGAIN, WITHOUT SUCCESS. THE PROCEDURE WAS COMPLETED AFTER A 2-HOUR DELAY WHEN THE SURGEON CUT THE RELEASE ROD OFF AT THE PEDICLE. NO OTHER MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED, NO ADDITIONAL TREATMENT IS EXPECTED, AND THE PATIENT IS DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 22167812 ↗
• MalfunctionJan 22, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD DIFFICULT OR DELAYED SEPARATION. - 1 EVENT HAD PATIENT INVOLVEMENT, NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207621 ↗
• MalfunctionJul 26, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD DIFFICULT OR DELAYED SEPARATION. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401944 ↗
• InjuryOct 20, 2022Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING A VERTEBROPLASTY PROCEDURE AT T11, A SPINEJACK IMPLANT WAS BEING MANIPULATED BY THE SURGEON. THE SURGEON ATTEMPTED TO REMOVE THE SPINEJACK IMPLANT, RESISTANCE WAS NOTED, AND THE SURGEON STOPPED. UPON REMOVAL OF THE EXPANDER TUBE, IT WAS FOUND THE IMPLANT HAD RELEASED SUBCUTANEOUSLY IN THE PATIENT TISSUE, AND IT WAS NOTED THERE WAS NO EXTRAVASATION OF CEMENT. THE SURGEON MADE A LARGER INCISION AND SURGICALLY REMOVED THE IMPLANT FROM THE PATIENT TISSUE. NO CLINICALLY SIGNIFICANT DELAY OCCURRED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE CEMENT FILL WAS REPORTED TO BE ADEQUATE IN THE VERTEBROPLASTY, AND NO ADDITIONAL FOLLOW UP OR MEDICAL INTERVENTION HAS BEEN INDICATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15640453 ↗