coflex Interlaminar Technology, 14mm UQI00014Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04260148898532), received between Jan 22, 2018 and Nov 15, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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 15, 2023Break; Break

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2023. IT WAS REPORTED THAT A PHYSICIAN HAD REACHED OUT AND WOULD LIKE TO DISCUSS A BROKEN IMPLANT. NO INFORMATION ON THE REPORTED IMPLANT MALFUNCTION, PATIENT HEALTH STATUS, OR CLINICAL PLAN FOR TREATMENT WERE PROVIDED. REPETITIVE ATTEMPTS TO COLLECT RELEVANT COMPLAINT INCIDENT INFORMATION FROM THE COMPLAINANT AND PHYSICIAN WERE INITIALLY UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142096 ↗
• InjuryJun 22, 2022Fracture; Fracture

  THE PATIENT WAS TREATED WITH COFLEX IMPLANTS IN THE LEVELS L3/L4 AND L4/L5 IN 2017 AND THE PATIENT REPORTED FEELING GREAT WITH NO BACK PAIN UNTIL APPROXIMATELY 2019 WHEN HE NOTED INCREASED BACK PAIN. THE PATIENT PRESENTED TO THE SURGEON A MONTH BEFORE THE REVISION SURGERY AND THE SURGEON RECOGNIZED THE FRACTURED IMPLANT AT THE L4/L5 LEVEL IN THE SAGITTAL RADIOGRAPH. THE SURGEON DETERMINED THAT A REVISION LUMBAR SURGERY WAS THE PREFERRED TREATMENT TO REDUCE THE PATIENT'S PAIN AND RESTORE STABILITY. THE IMPLANT WAS REMOVED WITH ADDITIONAL DECOMPRESSION PERFORMED. THE SURGEON DETERMINED THE PATIENT HAD SUFFICIENT STABILITY WITHOUT THE NEED FOR FUSION.

  Patient problems: Implant Pain

  MAUDE report 14767115 ↗
• InjuryJan 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SURGERY PERFORMED ON (B)(6) 2017 WAS A DECOMPRESSION WITH COFLEX INTERLAMINAR STABILIZATION AT THE L4/5 LEVEL. POST-OPERATIVE X-RAYS PERFORMED DID NOT IDENTIFY ANY ACUTE INJURIES OR FRACTURE. INITIAL POST-OP ASSESSMENT ON POD#1 PATIENT REPORTED COMPLETE RESOLUTION OF BILATERAL LEG AND HIP PAIN, HOWEVER CONTINUED TO COMPLAIN OF LOWER BACK PAIN RATED 6-7 OF 10. POD#2 PATIENT HAD AN ACTIVE DAY OF SHOPPING AND BEGAN TO COMPLAIN OF INCREASED PAIN WHICH SHE ATTRIBUTED TO TOO MUCH ACTIVITY. PAIN CONTINUED TO INCREASE. CT SCAN IDENTIFIED A FRACTURE OF THE L4 SPINOUS PROCESS. UPON FURTHER EVALUATION, IT WAS DETERMINED THAT THE BEST COURSE OF ACTION WOULD BE TO RE-EXPLORE THE SURGICAL AREA. RE-EXPLORATION OF AREA OCCURRED ON (B)(6) 2017. DURING THE OPERATION, THE COFLEX WAS REMOVED, AS WAS THE BROKEN SPINOUS PROCESS. PATIENT RECOVERED AND IS DOING WELL POST-OPERATIVELY.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 7208962 ↗