N/A 7480154Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00721902855658), received between Jan 21, 2021 and Dec 6, 2023 — 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 16, 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 6, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR SPINAL STENOSIS. IT WAS REPORTED THAT, THE PROBE WAS BENT AND THE OBTURATOR WAS BROKEN. THERE WAS NO FRAGMENT OF BROKEN INSTRUMENT LEFT INSIDE PATIENT BODY. PROCEDURE OR TECHNIQUE PERFORMED WAS SPINAL FUSION. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273689 ↗
• MalfunctionSep 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT THAT WAS USED IN A REVISION AND EXTENSION OF A POSTERIOR LUMBAR INTERBODY FUSION WITH PEDICLE SCREW FIXATION/STABILIZATION WITH MIDLINE APPROACH SPINAL THERAPY FOR BACK PAIN AND LEVELS IMPLANTED WERE L4/5. IT WAS REPORTED THAT THE SURGEON'S PLAN WAS TO REMOVE SCREWS AT L2, LEAVE SCREWS IN AT L3 AND PUT NEW SCREWS WITH OUR SOLERA 5.5 SYSTEM AT L4 WITH R90 INTERBODIES INSERTED AT L3/4. AS THE SURGEON WAS ATTEMPTING TO REMOVE A SET SCREW THE HEAD OF THE T27 OBTURATOR BROKE OFF WHEN ENGAGED WITH THE SET SCREW. THE BROKEN PIECE OF THE OBTURATOR WAS REMOVED FROM THE PATIENT. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE LOT NUMBER OF THE REPORTED PRODUCT IS PT04A005. THERE IS NO ALLEGATION/MALFUNCTION ASSOCIATED WITH THE INITIAL IMPLANTED PRODUCTS AND THE REASON FOR REVISION SURGERY WAS DUE TO SURGEON WANTED TO EXTEND FUSION CAUDALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15361767 ↗
• MalfunctionAug 10, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A T6 TO T12 REOPERATION TO REPOSITION PEDICLE SCREWS IN A PATIENT DIAGNOSED WITH BONE TUMOR IN SPINE. IT WAS REPORTED THAT THE INSTRUMENT BROKE. THERE WAS NO PATIENT SYMPTOM REPORTED. NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201054 ↗
• MalfunctionJan 21, 2021Break; Break

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH L2 EXTENSION OF F USION FROM PREVIOUS L3-FUSION AT L3-5 FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENT WAS INADVERTENTLY USED AS THE BREAK OFF DRIVER. THE TIP OF THE INSTRUMENT BROKE WHEN USED. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WAS NO FURTHER COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11208147 ↗