NA 498.110Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034788890), received between May 26, 2017 and Apr 10, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2018Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY ON AN UNKNOWN DATE FOR TREATMENT OF A POSTERIOR SPINAL FUSION WHERE THE PATIENT WAS IMPLANTED WITH THE SYNTHES UNIVERSAL SPINE SYSTEM (USS) CONSTRUCT AT UNKNOWN SPINE DISC LEVELS. POST-OPERATIVELY, ON (B)(6) 2013, A REVISION SURGERY WAS PERFORMED. THE REASON FOR THE PROCEDURE ON (B)(6) 2013, IS UNKNOWN. DURING THIS FOLLOW UP PROCEDURE THE SURGEON ADDED EXTENSION CONNECTORS THAT EXTEND THE PREVIOUSLY IMPLANTED SPINE CONSTRUCT. THIS EXTENSION TO THE ORIGINAL CONSTRUCT WAS ADDED AT T10 DISC LEVEL THRU THE ILIUM BONE. A ROD WAS REPORTED TO HAVE RUN CRANIAL TO THIS CONNECTOR. IT IS UNKNOWN WHAT LEVELS THE CRANIAL ROD GOES TO. THE CAUDAL ROD RAN TO THE PATIENT¿S ILIUM. POST-OPERATIVELY, AFTER THE PATIENT¿S FIRST REVISION SURGERY, IT WAS REPORTED THAT THE PATIENT HAD A BROKEN RIGHT ROD BETWEEN T10 THRU THE ILIUM BONE. THE RIGHT ROD WAS BROKEN BETWEEN THE L3 AND L4 DISC LEVELS WITH A NON-UNION. THE LEFT ROD WAS INTACT WITH NO ISSUES. ON (B)(6) 2018, ANOTHER REVISION SURGERY WAS PERFORMED TO ADDRESS THE PATIENT¿S BROKEN ROD AND NONUNION. THE SURGEON REMOVED THE LEFT AND RIGHT CAUDAL RODS. A SURGEON WAS ALSO REMOVED AND REPLACED PREVIOUSL

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

  MAUDE report 7412229 ↗
• InjuryFeb 2, 2018Break; Break

  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 1 MM 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 CONSEQU

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7238184 ↗
• InjuryMay 26, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO TWO 6.0MM TITANIUM (TI) HARD RODS THAT BROKE POSTOPERATIVELY.THE SURGEON INDICATED THAT THIS WAS DUE TO NOT HEALING AND HAVING A NONUNION. INITIALLY, THE PATIENT HAD A T10-L4 POSTERIOR SPINAL FUSION IN (B)(6) 2015 WITH SYNTHES UNIVERSAL SPINE SYSTEM (USS). AT AN UNKNOWN POINT IN TIME, THE PATIENT BROKE BOTH RODS. THE PATIENT HEARD OR FELT A POP IN THE AREA OF THE RODS. THE FAILURE WAS CONFIRMED BY X-RAY AT AN UNKNOWN TIME. IT IS UNKNOWN IF THE PATIENT HAD SYMPTOMS RELATED TO THE EVENT. IT IS UNKNOWN ABOUT PATIENT ACTIVITY OR IF THERE WERE ANY CONTRIBUTING FACTORS LEADING TO THE FAILURE OF THE DEVICE. THE EXACT POINT OF BREAKAGE OF THE ROD IS UNKNOWN. IT IS ALSO UNKNOWN THE SIZE OF THE USS SCREWS CRANIAL AND CAUDAL TO THE BREAK. DURING THE REVISION THE SURGEON EASILY REMOVED AND REPLACED BOTH RODS WITH NEW RODS. ALL FRAGMENTS WERE RETRIEVED. NO FURTHER INTERVENTION WAS REQUIRED. THE SURGEON ALSO USED NEW NUTS AND COLLARS TO CONNECT THE RODS TO ALL THE SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS REPORTED AFTER THE PROCEDURE STABLE. CONCOMITANT DEVICES REPORTED: USS SCREWS (UNKNOWN

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 6595366 ↗
• InjuryMay 26, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO TWO (2) 6.0MM TITANIUM (TI) HARD RODS THAT BROKE POSTOPERATIVELY. THE SURGEON INDICATED THAT THIS WAS DUE TO NOT HEALING AND HAVING A NONUNION. INITIALLY, THE PATIENT HAD A T10-L4 POSTERIOR SPINAL FUSION IN (B)(6) 2015 WITH SYNTHES UNIVERSAL SPINE SYSTEM (USS). AT AN UNKNOWN POINT IN TIME, THE PATIENT BROKE BOTH RODS. THE PATIENT HEARD OR FELT A POP IN THE AREA OF THE RODS. THE FAILURE WAS CONFIRMED BY X-RAY AT AN UNKNOWN TIME. IT IS UNKNOWN IF THE PATIENT HAD SYMPTOMS RELATED TO THE EVENT. IT IS UNKNOWN ABOUT PATIENT ACTIVITY OR IF THERE WERE ANY CONTRIBUTING FACTORS LEADING TO THE FAILURE OF THE DEVICE. THE EXACT POINT OF BREAKAGE OF THE ROD IS UNKNOWN. IT IS ALSO UNKNOWN THE SIZE OF THE USS SCREWS CRANIAL AND CAUDAL TO THE BREAK. DURING THE REVISION THE SURGEON EASILY REMOVED AND REPLACED BOTH RODS WITH NEW RODS. ALL FRAGMENTS WERE RETRIEVED. NO FURTHER INTERVENTION WAS REQUIRED. THE SURGEON ALSO USED NEW NUTS AND COLLARS TO CONNECT THE RODS TO ALL THE SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS REPORTED AFTER THE PROCEDURE STABLE. CONCOMITANT MEDICAL PRODUCTS: USS SCREWS (PAR

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 6595319 ↗