ENDOSKELETON® TL Hyperlordotic 7200-1088Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00191375045908), received between Oct 29, 2020 and Dec 16, 2022 — classified as 4 malfunctions.

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

• MalfunctionDec 16, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH DIRECT LATERAL LUMBAR INTERBODY FUSION THERAPY. IT WAS REPORTED THAT THE ONE SIDE OF THE TOP OF THE INSERTER BROKE OFF. IT WAS UNABLE TO BE DETERMINED IF THE TIP OF THE INSTRUMENT HAPPENED WHILE INSERTING IMPLANT OR WHEN TRYING TO REMOVE INSERTER FROM IMPLANT. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15993583 ↗
• MalfunctionJun 7, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR THE CAGE RECISION THERAPY. IT WAS REPORTED THAT THE DISTAL TIP OF INSERTER BROKE DURING INSERTION OF CAGE. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. PROCEDURE PERFORMED WAS OLIF <(>&<)> LEVEL IMPLANTED WAS L3-4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11944887 ↗
• MalfunctionDec 18, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH FUSION THERAPY. IT WAS REPORTED THAT DURING INSERTION THE POSTERIOR PART OF THE PLATE/GRAFT HOLDER BROKE. THERE WAS NO FRAGMENT LEFT OR CONTACT WITH THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11034364 ↗
• MalfunctionOct 29, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH DEGENERATIVE DISC DISEASE (DDD) FOR SPINAL OLIF FUSION THERAPY. IT WAS REPORTED THAT WHILE IMPLANTING THEIMPLANT, THE PRONG ON THE ALL-IN-ONE INTEGRATED INSERTER BROKE. SURGEON HAD TO REMOVE THE BROKEN INSTRUMENT, TAKE OUT THE BROKEN PIECE, REMOVE THE CAGE, AND IMPLANT VIA A DIFFERENT METHOD. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10753326 ↗