Spinal Jaxx Interbody Fusion Device 100001-627Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818956021006), received between Dec 8, 2022 and Dec 8, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

1 other recall cover devices cleared under the same FDA submission (K152501); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SURGEON PERFORMED A SURGERY ON (B)(6) 2022 IN WHICH HE IMPLANTED A SPINAL JAXX IMPLANT, EVERYTHING WENT FINE. THE PATIENT DID GREAT FOR A FEW WEEKS AFTER THE SURGERY, AND THEN DEVELOPED SEVERE LEG PAIN. SURGEON OBTAINED IMAGING STUDIES THAT SHOWED THE IMPLANT HAD BACKED OUT INTO THE CANAL. ON (B)(6) 2022, SURGEON PERFORMED A FOLLOW UP SURGERY WHICH WENT WELL, AFTER WHICH THE PATIENT FELT COMPLETE RELIEF. NOTHING WAS WRONG WITH THE IMPLANT AND SURGEON ATTRIBUTED THE BACKING OUT TO SURGEON ERROR DURING THE FIRST SURGERY. THE IMPLANT WAS REMOVED DURING THE SECOND SURGERY AND A NEW SPINAL JAXX IMPLANT WAS INSERTED DEEPER INTO THE INTERBODY SPACE. EVERYTHING HAS SEEMED FINE SINCE THEN.

  Patient problems: Pain

  MAUDE report 15940090 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152501. One submission often covers many models, so check the product and lot details in each record.

• Z-1350-2018 · Jan 18, 2018 · Terminated
  Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients