SpineJack 0909200042Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03760253800488), received between Jan 25, 2023 and May 5, 2026 — classified as 4 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 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.

• InjuryMay 5, 2026Separation Failure

  IT WAS REPORTED THAT A PATIENT WAS UNDERGOING MULTI-LEVEL TREATMENT FOR A VERTEBRAL COMPRESSION FRACTURE. AT L1, THE IMPLANT ON THE RIGHT SIDE WAS UNABLE TO DETACH FROM THE EXPANDER TUBE OF THE EXPANSION KIT. AFTER ATTEMPTS AT REMOVAL FAILED, ORTHO WAS CONSULTED AND THE EXPANDER TUBE AND WORKING CANNULA WERE CUT DOWN AS CLOSE AS POSSIBLE TO THE BONE. AS A RESULT, THE OTHER LEVEL OF THE PROCEDURE WAS NOT COMPLETED. TOTAL DELAY IN CASE WAS APPROXIMATELY 150 MINUTES. NO FURTHER ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25079954 ↗
• InjuryJun 14, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING AN L1 KYPHOPLASTY UTILIZING SPINEJACK, THE CANNULA WOULD NOT DETACH FROM SPINEJACK PRIOR TO INJECTING CEMENT. THE PHYSICIAN USED ADDITIONAL INSTRUMENTATION TO DETACH THE IMPLANT. HEIGHT RESTORATION WAS ACHIEVED, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY-SIGNIFICANT DELAY, AND NO ADDITIONAL MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124171 ↗
• InjuryApr 25, 2023Migration; Migration

  IT WAS REPORTED THAT DURING A STANDARD POST-OP X-RAY FOLLOWING A BIPEDICULAR T5 KYPHOPLASTY, THE IMPLANT HAD ESCAPED THE VERTEBRAL BODY. NO DELAY, MEDICAL INTERVENTION, OR ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED. ADDITIONAL MEDICAL FOLLOW-UP IS NOT EXPECTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808931 ↗
• MalfunctionApr 24, 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 16802923 ↗
• InjuryJan 25, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT AT THE END OF A PROCEDURE INVOLVING ABLATION OF THE PATIENT'S TUMOR AND IMPLANTATION OF SPINEJACK AT THE TUMOR LOCATION, THE PHYSICIAN HAD DIFFICULTY SEPARATING THE EXPANDER TUBE FROM THE DEPLOYED SPINEJACK IMPLANT. THE PHYSICIAN WAS ABLE TO DETACH THE EXPANDER TUBE BY PULLING THE IMPLANT BACK TOWARDS THE PATIENT'S PEDICLE AND THEN USED A TROCAR TO PUSH THE SPINEJACK IMPLANT AND CEMENT BACK INTO THE VERTEBRAL BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 25-30 MINUTE DELAY AND NO ADDITIONAL MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241590 ↗