coflex Interlaminar Technology, 12mm UQI00012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04260148898525), received between Jun 8, 2016 and Nov 30, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2023Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2023. IT WAS REPORTED THAT ONE OF THE SUPERIOR WINGS OF A SYSTEM IMPLANT FRACTURED DURING THE FINAL CRIMPING PROCESS. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE AVAILABLE SYSTEM IMPLANT WAS SUCCESSFULLY IMPLANTED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243652 ↗
• InjuryDec 19, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED PER MDR (B)(4): "THE PATIENT ORIGINALLY UNDERWENT A SURGERY FOR L3 4 L4 5 DECOMPRESSIVE LAMINECTOMY FOR LUMBAR SPINAL STENOSIS WITH POSTERIOR STABILIZATION USING THE COFLEX INTERSPINOUS PROCESS CLAMP ON (B)(6) 2016. NO COMPLICATIONS WERE REPORTED DURING THE ORIGINAL PROCEDURE. THE PATIENT DID RETURN FOR HOSPITALIZATION ON (B)(6) 2016 FOR DEVELOPMENT OF DRAINAGE FROM THE INCISION SITE THAT DID NOT SUBSIDE. ON (B)(6) 2016 THE PATIENT AGAIN RETURNED TO THE HOSPITAL FOR A SURGICAL PROCEDURE RELATED TO LOOSE ORTHOPEDIC IMPLANT AND REMOVAL OF THE POSTERIOR SPINAL INSTRUMENTATION. THE NEUROSURGEON DOCUMENTED THAT THE PATIENT RECENTLY WAS SEEN FOR WITH COMPLAINTS OF INCREASING LOWER BACK PAIN ASSOCIATED WITH MOVEMENT. THE DOCUMENTATION REVEALED THAT IT WAS SOMEWHAT MORE ON THE LEFT SIDE THAN THE RIGHT AND X-RAYS WERE OBTAINED THAT SHOWED THE COFLEX DEVICE HAD MIGRATED POSTERIORLY AND WAS NO LONGER IN THE INTERSPINOUS SPACE. REMOVAL WAS DONE IN HOPES OF HELPING THE PATIENT WITH HIS RESIDUAL BACK PAIN. THE NEUROSURGEON DOCUMENTED THAT FLEXION EXTENSION X-RAYS FAILED TO SHOW ANY OBVIOUS INSTABILITY. POST-OPERATIVE MRI SCAN SHOWED SUCCESSFUL DECOMPRESSION OF THE SPINAL CANAL. NO FU

  Patient problems: Pain

  MAUDE report 6185169 ↗
• InjuryJun 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COFLEX REVISION SURGERY - THE PATIENT'S SPINE DETERIORATED AROUND COFLEX IMPLANT

  Patient problems: Loss of Range of Motion; Pain; Stenosis

  MAUDE report 5705399 ↗