UNiD OCT B33143600-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03613720286899), received between Mar 29, 2022 and Nov 25, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. 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 25, 2022Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT, THE UNID ROD WAS FRACTURED. SURGEON DID NOT REMOVE THE FRACTURED ROD AND THEY USED ADDITIONAL ROD TO BRIDGE THE BROKE ROD. DURING THE PROCEDURE THE UNID RODS WERE PLACED IN THE SCREWS AND THE SCREWS WERE FINAL TIGHTENED. THEN THE SURGEON FELT LIKE THE PATIENT DIDN'T HAVE ENOUGH LUMBAR LORDOSIS SO, TRIED TO USE IN-SITU BENDERS TO ADD ADDITIONAL LORDOSIS. IN DOING THIS WITH ALL THE SCREWS LOCKED DOWN, IT CAUSED THE ROD TO FRACTURE NEAR THE L3-L4 AREA. THEN SURGEON USED AN ADDITIONAL ROD AND DOMINO CONNECTORS TO BRIDGE THE FRACTURED ROD. THE LEVELS IMPLANTED WITH REPORTED ROD WAS C2-PELVIS. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15863896 ↗
• MalfunctionJul 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T1 TO S1 POSTER IOR SPINAL FUSION FOR AN INDICATION OF PROXIMAL JUNCTIONAL KYPHOSIS. IT WAS REPORTED THAT THE ROD WAS MANUFACTURED FROM C3 TO L3. THE PORTION OF THE ROD ABOVE THE TRANSITION TO CERVICAL BROKE OFF DURING IMPLANTATION AND THE DISTAL PORTION, FROM T1 DOWN WAS RETAINED IN THE PATIENT. WHEN IMPLANTING THE ROD, THE SURGEON BENT THE ROD WITH BOTH THE IN SITU AND CORONAL BENDERS MULTIPLE TIMES IN TRYING TO GET THE CERVICAL PORTION OF THE ROD TO CONNECT INTO THE OPEN 3.5/3.5MM DOMINO CONNECTING THE NEW ROD TO THE PRE-EXISTING CONSTRUCT IN THE CERVICAL PORTION. AFTER MULTIPLE MANIPULATIONS, THE ROD BROKE AT THE TRANSITION. ATTEMPTS TO CONNECT THE TWO RODS WITH ATLAS CABLES FAILED THE RODS ON THE LEFT SIDE WERE NEVER CONNECTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15119908 ↗
• MalfunctionMar 29, 2022Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT THE ROD HAS FRACTURED AND WILL BE REMOVED IN NEW SURGERY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13936551 ↗