NA 498.106Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034788876), received between Aug 10, 2018 and Aug 10, 2018 — classified as 2 injuries.

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

• InjuryAug 10, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT WAS IMPLANTED WITH UNIVERSAL SPINAL SYSTEM (USS) FROM T10-ILIUM. ALL LEVELS HAD SCREWS PLACED FROM T10-ILIUM EXCEPT L2 AND AT THAT LEVEL, THE PATIENT HAD A PARALLEL CONNECTOR IN PLACE THAT CONNECTED TWO (2) RODS ON EACH SIDE. ON AN UNKNOWN DATE POST-OPERATIVE, THE HARD RODS BROKE BETWEEN L2-L3. ON (B)(6) 2018, PATIENT UNDERWENT A REVISION SURGERY DUE TO BROKEN BILATERAL TITANIUM HARD RODS THAT WERE CAUDAL TO THE TWO (2) TITANIUM PARALLEL CONNECTORS. DURING THE REVISION, THE SURGEON REMOVED ALL THE EIGHTEEN (18) USS NUTS, EIGHTEEN (18) COLLARS, TWO (2) HARD RODS AND (2) PARALLEL CONNECTORS. THE SURGEON THEN DECIDED TO PLACE NEW SCREWS AT T8 AND T9, CONTOURED NEW RODS AND CONNECTED THEM TO THE SCREWS WITH NEW USS NUTS AND COLLARS. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: SCREWS (PART#: UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN); TITANIUM PARALLEL CONNECTORS (PART#: 498.160, LOT# UNKNOWN, QUANTITY# 2); TITANIUM NUTS (PART#: 498.003, LOT# UNKNOWN, QUANTITY# 18); TITANIUM COLLARS (PART#: 498.010, LOT# UNKNOWN, QUANTITY# 18). THIS REPORT IS

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7773195 ↗
• InjuryAug 10, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT WAS IMPLANTED WITH UNIVERSAL SPINAL SYSTEM (USS) FROM T10-ILIUM. ALL LEVELS HAD SCREWS PLACED FROM T10-ILIUM EXCEPT L2 AND AT THAT LEVEL, THE PATIENT HAD A PARALLEL CONNECTOR IN PLACE THAT CONNECTED TWO (2) RODS ON EACH SIDE. ON AN UNKNOWN DATE POST-OPERATIVE, THE HARD RODS BROKE BETWEEN L2-L3. ON (B)(6) 2018, PATIENT UNDERWENT A REVISION SURGERY DUE TO BROKEN BILATERAL TITANIUM HARD RODS THAT WERE CAUDAL TO THE TWO (2) TITANIUM PARALLEL CONNECTORS. DURING THE REVISION, THE SURGEON REMOVED ALL THE EIGHTEEN (18) USS NUTS, EIGHTEEN (18) COLLARS, TWO (2) HARD RODS AND (2) PARALLEL CONNECTORS. THE SURGEON THEN DECIDED TO PLACE NEW SCREWS AT T8 AND T9, CONTOURED NEW RODS AND CONNECTED THEM TO THE SCREWS WITH NEW USS NUTS AND COLLARS. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: SCREWS (PART#: UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN); TITANIUM PARALLEL CONNECTORS (PART#: 498.160, LOT# UNKNOWN, QUANTITY# 2); TITANIUM NUTS (PART#: 498.003, LOT# UNKNOWN, QUANTITY# 18); TITANIUM COLLARS (PART#: 498.010, LOT# UNKNOWN, QUANTITY# 18). THIS REPORT IS

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7773194 ↗