coflex Interlaminar Technology, 10mm UQI00010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04260148898518), received between Dec 22, 2015 and Apr 30, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Break; Fracture; Break; Fracture

  ON MARCH 26, 2025, THE MANUFACTURER WAS NOTIFIED OF A POTENTIAL COMPLAINT INVOLVING A BROKEN DEVICE. THE MANUFACTURER REACHED OUT TO THE COMPLAINANT ON MARCH 27, 2025 AND APRIL 8, 2025. THE MANUFACTURER ALSO REACHED OUT TO THE SURGEON FOR MORE INFORMATION ON (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF THE REQUESTS. ON APRIL 13, 2025, THE COMPLAINANT SUBMITTED FURTHER DETAILS. IT WAS REPORTED THAT A PATIENT UNDERWENT A DECOMPRESSION AND IMPLANTATION PROCEDURE AT SPINAL LEVELS L3-L4 AND L4-L5 ON (B)(6) 2025. THE IMPLANT AT THE L3-L4 LEVEL WAS REPORTEDLY BROKEN UPON INSERTION; HOWEVER, THE ISSUE WAS NOT IDENTIFIED UNTIL APPROXIMATELY TWO MONTHS POSTOPERATIVELY. THE OPERATING SURGEON REPORTED THAT THERE WERE NO INTRAOPERATIVE COMPLICATIONS OR SURGICAL DELAYS. WHEN QUERIED REGARDING POTENTIAL REVISION, THE SURGEON RESPONDED: "OBSERVATION ONLY AT THIS TIME. NO ADDITIONAL SURGERY PLANNED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938812 ↗
• MalfunctionAug 24, 2017Break; Device Handling Problem; Break; Device Handling Problem

  WITHIN DAYS OF THE IMPLANTATION SURGERY, THE PATIENT HEARD A LARGE POP IN HER BACK. UPON EXAMINATION, THE DOCTOR DISCOVERED THAT THE COFLEX IMPLANT FRACTURED. FURTHER, IT WAS AT THIS TIME THAT THE SURGEON CONFIRMED THAT THE COFLEX DEVICE WAS BEING USED OFF-LABEL AND IN A MANNER NOT APPROVED BY FDA. AS A RESULT, THE PATIENT WAS FORCED TO UNDERGO A SECOND PROCEDURE TO REMOVE THE FRACTURED IMPLANT. SHE BEGAN TO EXPERIENCE BLADDER DYSFUNCTION AND URINARY INCONTINENCE. SHE CONTINUES TO EXPERIENCE EXTREME AND DEBILITATING BACK PAIN,

  Patient problems: Incontinence; Pain

  MAUDE report 6816378 ↗
• InjuryNov 10, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO (B)(4) THE PATIENT WAS RE-ADMITTED TO HOSPITAL ON (B)(6) 2016 AFTER DEVELOPING A CSF LEAK FOLLOWING DECOMPRESSIVE LAMINECTOMY FOR LUMBAR STENOSIS ON (B)(6) 2016. THE PATIENT WAS REPORTED TO HAVE HAD DRAINAGE FROM HER INCISION. ON (B)(6) 2016 THE PATIENT UNDERWENT THE SURGICAL PROCEDURE OF AN L3-4 AND L4-L5 DECOMPRESSION WITH POSTERIOR STABILIZATION USING COFLEX DEVICE AT L3-4 AND L4-5. NO COMPLICATIONS WERE REPORTED AS WELL AS REPORTS POSTOPERATIVELY THE PATIENT DID WELL AND WAS DISCHARGED HOME (B)(6) 2016. ON (B)(6) 2016 THE PATIENT PRESENTED TO THE HOSPITAL'S EMERGENCY DEPARTMENT WITH COMPLAINTS OF "HEADACHE/MUSCLE SPASMS" FOR PREVIOUS 24 HOURS. A CT OF HEAD WAS PERFORMED AND REPORTED TO ED AS NEGATIVE FOR ACUTE PATHOLOGY. THE PATIENT'S HEADACHE RESOLVED IN ED AND SHE WAS DISCHARGED HOME WITH FOLLOW UP TO NEUROSURGEON. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2016 BY THE NEUROSURGEON FOR "CSF LEAK". DUE TO REPORTED CSF LEAK THE PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2016 FOR REMOVAL OF THE HARDWARE (COFLEX) DEVICE AND REPAIR OF THE DUROTOMY. THE NEUROSURGEON OPERATIVE REPORT REVEALED 'DEEP RETRACTORS WERE PLACED WITHIN THE WOUND AND THE COFLEX HARDWARE W

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6092693 ↗
• InjuryDec 22, 2015Insufficient Device Problem Information

  THIS CASE WAS AN ADJACENT LEVEL CASE TO A FUSION THAT HAD A POST OP INFECTION AND WAS LOOSENED AFTER EXPLORATION AND REMOVAL. LOOSENING IS THE CONSEQUENCE OF INFECTION AND INFECTION IS THE NET REASON FOR REOPERATION.

  Patient problems: Unspecified Infection

  MAUDE report 5317504 ↗