NA 498.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034788586), received between Dec 6, 2017 and Dec 5, 2019 — classified as 7 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION OF UNIVERSAL SPINAL SYSTEM (USS) SYNTHES DEVICES DUE TO AN UNKNOWN POINT IN TIME THE LEFT L2 NUT AND COLLAR CAME OFF OF THE SCREW.

  Patient problems: No Code Available

  MAUDE report 9418017 ↗
• InjurySep 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT HAD AN L4-ILIUM POSTERIOR SPINAL FUSION WITH SYNTHES UNIVERSAL SPINAL SYSTEM (USS). AT AN UNKNOWN TIME, THE PATIENT DEVELOPED BACK PAIN, AND ALSO AN ADJACENT LEVEL DISC DISEASE ABOVE THE FUSION. THE SURGEON PERFORMED THE REVISION SURGERY ON (B)(6) 2018, THEN REMOVED ALL THE NUTS, COLLARS, AND BOTH RODS. WHILE REMOVING THE RODS, THE SURGEON DISCOVERED THAT THE LEFT ROD WAS BROKEN JUST CRANIAL TO THE LEFT S1 SCREW. THE SURGEON PLACED A NEW USS SCREWS AT L2 AND L3, AND CONTOURED NEW RODS, AND CONNECTED THEM TO THE SCREWS FROM L2-ILIUM. THE SURGEON DID NOT REPLACE ANY OF THE L4-ILIUM SCREWS FROM THE (B)(6) 2018 SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS 7 OF 7 FOR (B)(4) TESTS/LAB DATA.

  Patient problems: Pain

  MAUDE report 7916492 ↗
• InjurySep 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT HAD AN L4-ILIUM POSTERIOR SPINAL FUSION WITH SYNTHES UNIVERSAL SPINAL SYSTEM (USS). AT AN UNKNOWN TIME, THE PATIENT DEVELOPED BACK PAIN, AND ALSO AN ADJACENT LEVEL DISC DISEASE ABOVE THE FUSION. THE SURGEON PERFORMED THE REVISION SURGERY ON (B)(6) 2018, THEN REMOVED ALL THE NUTS, COLLARS, AND BOTH RODS. WHILE REMOVING THE RODS, THE SURGEON DISCOVERED THAT THE LEFT ROD WAS BROKEN JUST CRANIAL TO THE LEFT S1 SCREW. THE SURGEON PLACED A NEW USS SCREWS AT L2 AND L3, AND CONTOURED NEW RODS, AND CONNECTED THEM TO THE SCREWS FROM L2-ILIUM. THE SURGEON DID NOT REPLACE ANY OF THE L4-ILIUM SCREWS FROM THE (B)(6) 2018 SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS 3 OF 7 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7916463 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT DESCRIPTION HAS BEEN UPDATED: IT WAS REPORTED THAT THE PATIENT HAD A T10-S2 POSTERIOR FUSION WITH SYNTHES UNIVERSAL SPINAL SYSTEM (USS) IN 2005. AT AN UNKNOWN POINT IN TIME, THE PATIENT BROKE THE RIGHT ROD BETWEEN L5 AND S1 AND A NON-UNION DEVELOPED. THE LEFT ROD IS INTACT. THE PATIENT ALSO DEVELOPED PROXIMAL JUNCTIONAL KYPHOSIS ABOVE THE CONSTRUCT. ON (B)(6) 2018 THE PATIENT UNDERWENT A REVISION AND BOTH RODS WERE REMOVED. THE RIGHT ROD FRAGMENTS WERE EASILY RETRIEVED. THE LEFT ROD WAS REMOVED RELATED TO NON-UNION AT THE SITE. THE SURGEON REPLACED SEVERAL SCREWS BETWEEN T10 AND S1 (THE SIZE AND WHAT SCREWS WERE REPLACED ARE UNKNOWN). IN ADDITION, THE S2 SCREWS WERE REMOVED. TO TREAT THE PROXIMAL JUNCTIONAL KYPHOSIS THE SURGEON PLACED NEW SCREWS AT T6-T9 AND CONTOURED THE NEW RODS AND CONNECTED THEM TO THE SCREWS. ILIAC SCREWS WERE PLACED AND CONNECTED TO THE RODS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM WAS REPORTED. THIS REPORT IS FOR ONE (1) TITANIUM COLLAR. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7403651 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT DESCRIPTION HAS BEEN UPDATED: IT WAS REPORTED THAT THE PATIENT HAD A T10-S2 POSTERIOR FUSION WITH SYNTHES UNIVERSAL SPINAL SYSTEM (USS) IN 2005. AT AN UNKNOWN POINT IN TIME, THE PATIENT BROKE THE RIGHT ROD BETWEEN L5 AND S1 AND A NON-UNION DEVELOPED. THE LEFT ROD IS INTACT. THE PATIENT ALSO DEVELOPED PROXIMAL JUNCTIONAL KYPHOSIS ABOVE THE CONSTRUCT. ON (B)(6) 2018 THE PATIENT UNDERWENT A REVISION AND BOTH RODS WERE REMOVED. THE RIGHT ROD FRAGMENTS WERE EASILY RETRIEVED. THE LEFT ROD WAS REMOVED RELATED TO NON-UNION AT THE SITE. THE SURGEON REPLACED SEVERAL SCREWS BETWEEN T10 AND S1 (THE SIZE AND WHAT SCREWS WERE REPLACED ARE UNKNOWN). IN ADDITION, THE S2 SCREWS WERE REMOVED. TO TREAT THE PROXIMAL JUNCTIONAL KYPHOSIS THE SURGEON PLACED NEW SCREWS AT T6-T9 AND CONTOURED THE NEW RODS AND CONNECTED THEM TO THE SCREWS. ILIAC SCREWS WERE PLACED AND CONNECTED TO THE RODS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM WAS REPORTED. THIS REPORT IS FOR ONE (1) TITANIUM COLLAR. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7403626 ↗
• InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION PROCEDURE OF TWO (2) NUTS, TWO (COLLARS), AND TWO (2) SCREWS BELONGING TO SYNTHES USS CONSTRUCT FROM L2 VERTEBRA ON (B)(6) 2017. TWO (2) INITIALLY IMPLANTED CAUDAL RODS WERE LEFT IN THE PATIENT AND CONNECTED TO NEW RODS USING ROD TO ROD CONNECTORS. THE PATIENT HAD A L2-ILIUM POSTERIOR FUSION WITH SYNTHES USS IN (B)(6) 2016. THE PATIENT IS REPORTED TO HAVE INCREASING BACK PAIN SINCE THE TIME OF THE INITIAL FUSION PROCEDURE, POSSIBLY DUE TO DEGENERATIVE DISC DISEASE AND STENOSIS ABOVE THE LEVELS OF THE (B)(6) 2016 FUSION PROCEDURE. AFTER REMOVING THE NUTS, COLLARS AND SCREWS FROM L2 VERTEBRA BILATERALLY, THE SURGEON INSERTED ROD TO ROD CONNECTORS ON THE EXISTING RODS AT L2 FOLLOWED BY PLACING NEW SCREWS AT T10, T11, T12 AND L1. THE SURGEON THEN CONNECTED THE EXISTING CAUDAL RODS TO THE NEW CRANIAL RODS WITH THE ROD TO ROD CONNECTORS BILATERALLY, THUS CONCLUDING THE PROCEDURE. THE REMOVAL AND REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY AND UNEVENTFULLY WITH NO ADDITIONAL INTERVENTIONS REQUIRED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THIS IS REPORT 3 OF 6 FOR (B)(6).

  Patient problems: No Code Available; Pain; Stenosis

  MAUDE report 7088560 ↗
• InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION PROCEDURE OF TWO (2) NUTS, TWO (COLLARS), AND TWO (2) SCREWS BELONGING TO SYNTHES USS CONSTRUCT FROM L2 VERTEBRA ON (B)(6) 2017. TWO (2) INITIALLY IMPLANTED CAUDAL RODS WERE LEFT IN THE PATIENT AND CONNECTED TO NEW RODS USING ROD TO ROD CONNECTORS. THE PATIENT HAD A L2-ILIUM POSTERIOR FUSION WITH SYNTHES USS IN (B)(6) 2016. THE PATIENT IS REPORTED TO HAVE INCREASING BACK PAIN SINCE THE TIME OF THE INITIAL FUSION PROCEDURE, POSSIBLY DUE TO DEGENERATIVE DISC DISEASE AND STENOSIS ABOVE THE LEVELS OF THE (B)(6) 2016 FUSION PROCEDURE. AFTER REMOVING THE NUTS, COLLARS AND SCREWS FROM L2 VERTEBRA BILATERALLY, THE SURGEON INSERTED ROD TO ROD CONNECTORS ON THE EXISTING RODS AT L2 FOLLOWED BY PLACING NEW SCREWS AT T10, T11, T12 AND L1. THE SURGEON THEN CONNECTED THE EXISTING CAUDAL RODS TO THE NEW CRANIAL RODS WITH THE ROD TO ROD CONNECTORS BILATERALLY, THUS CONCLUDING THE PROCEDURE. THE REMOVAL AND REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY AND UNEVENTFULLY WITH NO ADDITIONAL INTERVENTIONS REQUIRED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THIS IS REPORT 1 OF 6 FOR (B)(6)..

  Patient problems: No Code Available; Pain; Stenosis

  MAUDE report 7088453 ↗