NA 498.745Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034791616), received between Feb 2, 2018 and Feb 15, 2018 — classified as 2 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, A PATIENT UNDERWENT A REVISION OF SYNTHES USS HARDWARE SINCE THE PATIENT EXPERIENCED PAIN AND ONE (1) LEFT S1 SCREW BROKE DUE TO NONUNION. THE PATIENT UNDERWENT A POSTERIOR LUMBAR SPINE FUSION WITH SYNTHES USS ON (B)(6) 2010 FOR AN UNKNOWN SPINAL FRACTURE. SUBSEQUENTLY, NONUNION AND BROKEN SCREW WERE IDENTIFIED IN FOLLOW-UP X-RAYS AND THE SURGEON DECIDED TO REVISE ALL HARDWARE. ALL HARDWARE WAS REMOVED EXCEPT THE SHAFT OF THE BROKEN LEFT S1 SCREW WHICH WAS NOT RETRIEVABLE. THE PATIENT WAS REVISED TO ONE (1) NEW SCREW BILATERALLY AT L5 LEVEL, ONE (1) RIGHT S1 AND BILATERALLY IN THE ILIUM (EXTENDED TO THE ILIUM) AND BY CONNECTING NEW RODS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT CONDITION WAS REPORTED TO BE MOST LIKELY STABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. CONCOMITANT DEVICES REPORTED: TITANIUM NUTS (PART# 498.003, LOT# UNKNOWN, QUALITY# 4); TITANIUM COLLARS WITH GROOVES (PART# 498.011, LOT# UNKNOWN, QUANTITY# 4); 6 MM TITANIUM HARD RODS (PART# 498.102, LOT# UNKNOWN, QUANTITY# 2); UNKNOWN USS SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 7275440 ↗
• InjuryFeb 2, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THE PATIENT UNDERWENT A UNIVERSAL SPINE SYSTEM (USS) REVISION ON (B)(6) 2018 DUE TO ONE (1) BROKEN ROD AND TWO (2) LOOSE SCREWS. THE PATIENT REPORTED THAT SHE FELT A POP IN HER LOWER BACK IN (B)(6). ON IMAGING, THE SURGEON SAW THAT THE PATIENT HAD BROKEN THE RIGHT ROD JUST BELOW THE S1 SCREW (BROKEN BETWEEN S1 AND ILIAC SCREW). DURING THE REVISION, THE SURGEON REMOVED THE NUTS AND COLLARS FROM THE RIGHT L5 SCREW AND THE RIGHT ILIAC SCREW. HE THEN REPLACED THE RIGHT ILIAC SCREW AND THE RIGHT L5 SCREW. HE SAID THAT THE SCREWS WERE SLIGHTLY LOOSE IN THE BONE. HE REPLACED THEM WITH NEW USS SCREWS THAT WERE 1MM LARGER IN DIAMETER. HE THEN CUT A NEW ROD AND PLACED AN EXPEDIUM UNIVERSAL CONNECTOR ON THE CRANIAL PART OF THE NEW ROD. HE THEN TURNED THE NEW L5 SCREW SO THE SIDE OPENING FACED LATERAL. HE CONNECTED THE NEW ROD TO THE EXISTING RIGHT ROD USING THE EXPEDIUM CONNECTOR BETWEEN THE L2 AND L3 SCREW HEADS. HE THEN CONNECTED THE L5 AND ILIAC SCREWS TO THE NEW ROD. THE OLD RIGHT ROD RAN FROM T4-S1. THE NEW RIGHT ROD RAN ALONG SIDE THE OLD ROD. THE PATIENT WAS INITIALLY IMPLANTED WITH THE USS HARDWARE FROM T4-ILIUM IN (B)(6) 2017. NO REPORTED DELAY AND NO PATIENT CONSEQUE

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7238186 ↗