NA 04.600.016Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034734125), received between Aug 18, 2017 and Jun 4, 2019 — 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION OF A T10-ILIUM OF THE POSTERIOR SPINAL FUSION DUE TO A BROKEN RIGHT ROD BETWEEN L5 AND S1. THE PATIENT ALSO HAS A FRACTURE AT T9. NEW USS SCREWS WERE PLACED T6, T7, T8, NEW RODS WERE CONTOURED AND CONNECTED IT TO THE USS SCREWS. THE NEW CONSTRUCT WAS T6-ILIUM. THE ORIGINAL DATE OF THE IMPLANT WAS IN (B)(6) 2017. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 8667828 ↗
• InjurySep 19, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD A T10-ILIUM POSTERIOR SPINAL FUSION WITH SYNTHES UNIVERSAL SPINAL SYSTEM (USS) ON (B)(6) 2017. ON AN UNKNOWN POSTOPERATIVE DATE, THE PATIENT BROKE THE LEFT ROD JUST CAUDAL TO THE S1 SCREW. THE RIGHT ROD WAS INTACT. THE PATIENT ALSO DEVELOPED PROXIMAL JUNCTIONAL KYPHOSIS ABOVE THE TOP OF THE CONSTRUCT. THE SURGEON PERFORMED REVISION SURGERY ON (B)(6) 2018, AND REMOVED BOTH RODS. THE SURGEON THEN PLACED NEW USS SCREWS ABOVE THE PREVIOUS FUSION AT T7, T8, AND T9 TO ADDRESS AND CORRECT THE PATIENT'S KYPHOSIS. THE SURGEON THEN CONTOURED NEW RODS AND CONNECTED THEM FROM T7-ILIUM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: USS SCREWS, PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN; TITANIUM COLLAR, PART: 498.010, LOT: UNKNOWN, QUANTITY: 2; TITANIUM NUT 11MM WIDTH ACROSS FLATS, PART: 498.003, LOT: UNKNOWN, QUANTITY: 2; ROD, PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1. THIS REPORT IS FOR A 6.0MM TITANIUM (TI) PRECONTOURED ROD 65MM STRAIGHT LENGTH/400MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7890549 ↗
• InjuryAug 18, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD A T10-ILIUM POSTERIOR SPINE FUSION USING THE SYNTHES UNIVERSAL SPINE SYSTEM (USS) ON (B)(6) 2017. AT TOTAL OF TWENTY USS 9.0MM SCREWS (WITH COLLAR AND NUTS) AND TWO 2 RODS WERE ORIGINALLY IMPLANTED. AT AN UNKNOWN TIME AFTER THIS SURGERY THE PATIENT BROKE BOTH RODS BETWEEN THE L2-L3 LEVELS. IT IS UNKNOWN HOW THE PATIENT BECAME AWARE OF THIS. SURGEON DID REPORT THAT THE PATIENT WAS IN AN AUTOMOBILE ACCIDENT AFTER HIS SURGERY AT AN UNKNOWN TIME. SURGEON PERFORMED THE REVISION ON (B)(6) 2017. DURING THE REVISION, SURGEON REMOVED THE USS NUTS AND COLLARS AND THEN REMOVED THE TWO BROKEN RODS. EACH OF THE RODS WERE BROKEN BETWEEN L2 AND L3 DISC POSITION ON BOTH. SURGEON THEN CHECKED THE BONE PURCHASE OF THE SCREWS THAT WERE IMPLANTED FROM THE (B)(6) 2017 SURGERY. AT THE L2 AND L3 LEVELS, HE REPLACED ONLY THE RIGHT L2 SCREWS DUE TO BETTER BONE PURCHASE TO SUPPORT THE NEW ROD THAT WAS TO BE IMPLANTED. AT THIS LEVEL HE REMOVED A 9.0 X 60MM SCREW AND REPLACED WITH LARGER USS SCREW. ALSO, DURING THE REVISION IT WAS NOTED THAT THERE WERE APPROXIMATELY FIVE (5) EACH (EXACT NUMBER OF SCREWS ARE UNKNOWN) 9.0MM TI SIDE OPENING SCREWS (SPECIFIC DYNAMITER UNKNOWN)

  Patient problems: Failure of Implant

  MAUDE report 6804886 ↗
• InjuryAug 18, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD A T10-ILIUM POSTERIOR SPINE FUSION USING THE SYNTHES UNIVERSAL SPINE SYSTEM (USS) ON (B)(6) 2017. AT TOTAL OF TWENTY USS 9.0MM SCREWS (WITH COLLAR AND NUTS) AND TWO 2 RODS WERE ORIGINALLY IMPLANTED. AT AN UNKNOWN TIME AFTER THIS SURGERY THE PATIENT BROKE BOTH RODS BETWEEN THE L2-L3 LEVELS. IT IS UNKNOWN HOW THE PATIENT BECAME AWARE OF THIS. SURGEON DID REPORT THAT THE PATIENT WAS IN AN AUTOMOBILE ACCIDENT AFTER HIS SURGERY AT AN UNKNOWN TIME. SURGEON PERFORMED THE REVISION ON (B)(6) 2017. DURING THE REVISION, SURGEON REMOVED THE USS NUTS AND COLLARS AND THEN REMOVED THE TWO BROKEN RODS. EACH OF THE RODS WERE BROKEN BETWEEN L2 AND L3 DISC POSITION ON BOTH. SURGEON THEN CHECKED THE BONE PURCHASE OF THE SCREWS THAT WERE IMPLANTED FROM THE (B)(6) 2017 SURGERY. AT THE L2 AND L3 LEVELS, HE REPLACED ONLY THE RIGHT L2 SCREWS DUE TO BETTER BONE PURCHASE TO SUPPORT THE NEW ROD THAT WAS TO BE IMPLANTED. AT THIS LEVEL HE REMOVED A 9.0 X 60MM SCREW AND REPLACED WITH LARGER USS SCREW. ALSO, DURING THE REVISION IT WAS NOTED THAT THERE WERE APPROXIMATELY FIVE (5) EACH (EXACT NUMBER OF SCREWS ARE UNKNOWN) 9.0MM TI SIDE OPENING SCREWS (SPECIFIC DYNAMITER UNKNOWN)

  Patient problems: Failure of Implant

  MAUDE report 6804871 ↗