NA 498.292Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034789965), received between Mar 5, 2018 and Mar 26, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD A POSTERIOR SPINAL FUSION WITH A COMBINATION OF SYNTHES UNIVERSAL SPINE SYSTEM (USS) AND SYNTHES USS VARIABLE ACCESS SCREW (VAS) III ON (B)(6) 2016. AT AN UNKNOWN POINT IN TIME, THE PATIENT BROKE THE RIGHT ROD BETWEEN L5 AND S1 DISC SPACE. POST-OPERATIVE, ON (B)(6) 2017, SURGEON PERFORMED THE REVISION. SURGEON REMOVED ALL THE USS AND USS VAS III NUTS AND COLLARS BELOW T12. AT T12 THERE WAS ALSO A EXTENSION CONNECTOR CONNECTING RODS CRANIAL AND CAUDAL TO THE CONNECTOR. SURGEON THEN REMOVED BOTH THE LEFT AND RIGHT RODS BELOW THE CONNECTOR. SURGEON THEN REPLACED SEVERAL LOOSE SCREWS AT UNKNOWN LEVELS - UNKNOWN SCREWS THAT CAME OUT OR WERE REPLACED. SURGEON THEN CONTOURED NEW RODS AND PLACED THEM INTO THE EXISTING EXTENSION CONNECTORS. HE THEN CONNECTED THE RODS TO THE SCREWS. HE THEN REPLACED THE RIGHT AND LEFT ILIAC SCREWS, AND THEN PLACED A SECOND SET OF ILIAC SCREWS BILATERALLY AND CONNECTED THEM TO THE RODS. SURGERY WAS COMPLETE SUCCESSFULLY AND PATIENT IS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: TITANIUM NUT 11 MM WIDTH ACROSS FLATS (498.003, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN), TITANIUM COLLAR FOR USS VARIABLE AXIS SCREWS

  Patient problems: Failure of Implant

  MAUDE report 7371400 ↗
• InjuryMar 5, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY (B)(6) 2012, FOR TREATMENT FOR A T12-ILIUM POSTERIOR SPINAL FUSION USING THE SYNTHES DUAL OPENING UNIVERSAL SPINE SYSTEM (USS) IMPLANTS. THE PATIENT WAS ORIGINALLY IMPLANTED WITH TWO (2) USS 6.0MM/ 300MM RODS, USS COLLARS FOR 6MM DUAL-OPENING IMPLANTS, USS 11MM NUTS AND USS DUAL OPENING SCREWS. ON AN UNKNOWN DATE POST-OPERATIVELY, IT WAS OBSERVED THRU IMAGE STUDIES THAT THE BILATERAL ROD IMPLANTS BETWEEN L5 AND S1 WERE BROKEN. THE PATIENT ALSO PRESENTED WITH A NONUNION AT THE L5-S1 DISC LEVEL. ON (B)(6) 2018, THE SURGEON REMOVED THE ROD IMPLANTS BILATERALLY. THE RODS WERE REMOVED IN ENTIRETY WITHOUT ANY FRAGMENTS IN FOUR (4) SEGMENTS. THE SURGEON ALSO REPLACED SOME OF THE USS DUAL OPENING SCREWS THAT WERE DEEMED TO BE LOOSE IN BONE. IT IS UNKNOWN WHICH OF THE DUAL OPENING SCREWS WERE REPLACED. ALL IMPLANTS HAVE BEEN RETAINED BY THE PATIENT. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. THE PATIENT IS REPORTED IN STABLE CONDITION. SALES CONSULTANT HAS NO MORE INFORMATION TO REPORT ON THIS EVENT. CONCOMITANT DEVICES REPORTED: TITANIUM 12 POINT NUT 11MM (499.294, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN); TITANIUM COL

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7314559 ↗
• InjuryMar 5, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY (B)(6) 2012, FOR TREATMENT FOR A T12-ILIUM POSTERIOR SPINAL FUSION USING THE SYNTHES DUAL OPENING UNIVERSAL SPINE SYSTEM (USS) IMPLANTS. THE PATIENT WAS ORIGINALLY IMPLANTED WITH TWO (2) USS 6.0MM/ 300MM RODS, USS COLLARS FOR 6MM DUAL-OPENING IMPLANTS, USS 11MM NUTS AND USS DUAL OPENING SCREWS. ON AN UNKNOWN DATE POST-OPERATIVELY, IT WAS OBSERVED THRU IMAGE STUDIES THAT THE BILATERAL ROD IMPLANTS BETWEEN L5 AND S1 WERE BROKEN. THE PATIENT ALSO PRESENTED WITH A NONUNION AT THE L5-S1 DISC LEVEL. ON (B)(6) 2018, THE SURGEON REMOVED THE ROD IMPLANTS BILATERALLY. THE RODS WERE REMOVED IN ENTIRETY WITHOUT ANY FRAGMENTS IN FOUR (4) SEGMENTS. THE SURGEON ALSO REPLACED SOME OF THE USS DUAL OPENING SCREWS THAT WERE DEEMED TO BE LOOSE IN BONE. IT IS UNKNOWN WHICH OF THE DUAL OPENING SCREWS WERE REPLACED. ALL IMPLANTS HAVE BEEN RETAINED BY THE PATIENT. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. THE PATIENT IS REPORTED IN STABLE CONDITION. SALES CONSULTANT HAS NO MORE INFORMATION TO REPORT ON THIS EVENT. CONCOMITANT DEVICES REPORTED: TITANIUM 12 POINT NUT 11MM (499.294, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN), TITANIUM COL

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7314537 ↗