NA 498.104Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034788852), received between Oct 16, 2018 and Jan 7, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT USS DUAL OPENING HARDWARE REMOVAL SURGERY DUE TO BROKEN HARDWARE. THE SURGEON REMOVED THE POSTERIOR USS DUAL OPENING HARDWARE THAT WAS IMPLANTED IN THE YEAR 2012 DUE TO A THORACOLUMBAR SPINE FRACTURE. THERE WERE TWO (2) ISSUES WITH THE HARDWARE FROM THE 2012 SURGERY. THE LEFT ROD WAS BROKEN JUST CRANIAL TO THE L2 SCREW. ALSO, THE RIGHT L2 SCREW WAS BROKEN JUST BELOW THE HEAD OF THE SCREW. IT IS UNKNOWN WHEN THE HARDWARE BROKE. THERE WERE NO SCREWS PLACED AT L1 THE LEVEL OF THE FRACTURE. ALL THE HARDWARE WAS EASILY REMOVED, BUT THE TIP OF THE BROKEN SCREW REMAINS IN THE RIGHT L2 PEDICLE. THE SURGEON DECIDED THAT THERE IS NO PROBLEM LEAVING THIS BROKEN SCREW IN THE PATIENT AND THAT THERE WAS A RISK OF HARM TO THE PATIENT BY TRYING TO REMOVE THE BROKEN SCREW. THE PATIENT HAS SUCCESSFULLY HEALED AND THE REMOVAL WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE: LOCKING/SET SCREWS: USS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN) 6.2MM TI DUAL-OPENING SCREW 45MM THRD LENGTH F/6.0MM RODS (PART NUMBER 499.223, LOT 6965910, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 6.0MM TI HARD ROD 100MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11132617 ↗
• InjuryNov 2, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY DUE TO BROKEN LEFT ROD AND LOOSENED 3 SCREWS IN BOTH S1 AND LEFT L5. THE PATIENT HAD A L3-S1 (NO SCREW AT LEFT L4) POSTERIOR SPINAL FUSION WITH SYNTHES USS ON (B)(6) 2018. AT AN UNKNOWN POINT IN TIME THE PATIENT BROKE THE LEFT ROD JUST CRANIAL TO THE S1 SCREW. THE SURGEON SAID THAT THE PATIENT HAS A NON UNION AT L5-S1. DURING THE REVISION SURGERY, THE SURGEON REMOVED BOTH RODS. BOTH S1 SCREWS, AND THE LEFT L5 SCREWS WERE REPLACED WITH LARGER DIAMETER USS SCREWS. THE SURGEON PLACED NEW RODS, CONNECTED THEM AND SUCCESSFULLY COMPLETED THE PROCEDURE. THE RODS REMOVED FROM THE 2018 PROCEDURE WERE 6.0MM TITANIUM HARD RODS. THERE IS NO ALLEGATION WITH THE RIGHT ROD. THE REASON WHY THE SURGEON ALSO REMOVED THE RIGHT ROD WAS SURGEON WANTED TO REPLACED THE RIGHT ROD BECAUSE HE WAS ALREADY EXPOSED TO REPLACE THE LEFT ROD. IT CAN BE ASSUMED THAT THE RIGHT ROD WOULD BE ¿WEAKENED¿ ALTHOUGH NOT BROKEN. HE WANTED TWO (2) NEW RODS TO GIVE THE PATIENT THE BEST POSSIBLE CHANCE TO HEAL. IT WAS UNKNOWN THE SIZES/LOTS OF THE 3 SCREWS THAT WERE REMOVED AND REPLACED. THERE WAS NO PATIENT CONSEQUENCE. THI

  Patient problems: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture

  MAUDE report 10771000 ↗
• InjuryJun 6, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON PERFORMED SPINAL FUSION AND A POSTERIOR REVISION PROCEDURE DUE TO PATIENT HAD DEVELOPED AN ADJACENT LEVEL DISC DISEASE AND STENOSIS ABOVE THE PREVIOUS FUSION AT THE L2-L3 LEVEL. DURING A REMOVAL OF BOTH TITANIUM HARD RODS FROM THE 2014 SURGERY, IT WAS DISCOVERED THAT THE LEFT ROD HAD BROKEN BETWEEN L3 AND L4. THE ROD DID NOT BREAK DURING SURGERY. IT BROKE AT AN UNKNOWN TIME PRIOR TO THE REVISION SURGERY. THE PATIENT DID NOT HAVE NON UNION BECAUSE THE BROKEN ROD WENT ON TO HEAL AND HAVE HAD A SOLID FUSION BETWEEN L3-L5.  ALL DATES WERE UNKNOWN. THE SURGEON PLACED NEW SCREWS AT THE L2 LEVEL. THERE WERE NO ALLEGATION AGAINST THE SCREWS. AFTER THE DECOMPRESSION, NEW RODS WERE PLACED AND THEN CONNECTED. THE NEW CONSTRUCT IS SYNTHES USS L2-L5. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1); UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available; Stenosis

  MAUDE report 8675826 ↗
• InjuryMar 19, 2019Break; Break

  THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8434260 ↗
• InjuryMar 19, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD A L1-L3 POSTERIOR SPINAL FUSION WITH SYNTHES USS DUAL OPENING IN (B)(6) 2017 TO STABILIZE A L2 TRAUMATIC BURST FRACTURE REVISION DUE TO BROKEN ROD. THE PATIENT HAD A L1-L3 POSTERIOR SPINAL FUSION WITH SYNTHES UNIVERSAL SPINAL SYSTEM (USS) DUAL OPENING ON (B)(6) 2017 TO STABILIZE A L2 TRAUMATIC BURST FRACTURE. ON THE RIGHT THERE ARE SCREWS AT L1, L2, AND L3. ON THE LEFT THERE ARE SCREWS AT L1 AND L3 - NO SCREW AT L2. AT AN UNKNOWN POINT IN TIME, THE PATIENT BROKE BOTH RODS JUST CRANIAL TO L2. ON THE FIRST STAGE OF THE REVISION, THE SURGEON DID A L2 CORPECTOMY AND PLACED A DEPUY SYNTHES VERTEBRAL BODY REPLACEMENT DEVICE (XRL) CAGE FROM A LATERAL APPROACH. ON THE NEXT STAGE, THE SURGEON DID THE POSTERIOR REVISION OF THE USS DUAL OPENING HARDWARE AND REMOVED THE LEFT AND RIGHT RODS. ALL PIECES WERE REMOVED AND LEFT THE EXISTING SCREWS IN PLACE. THEN PLACED NEW RODS AND CONNECTED THEM TO THE SCREWS AND SUCCESSFULLY COMPLETED THE PROCEDURE. PATIENT STATUS IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN LOCKING/SET SCREWS USS (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY UNKNOWN). UNK - VERT BODY REPLACE - EXP: XRL (PART # UNKNOWN, LOT # UNKNO

  Patient problems: No Code Available

  MAUDE report 8434259 ↗
• InjuryOct 16, 2018Break; Break

  IT WAS REPORTED ON (B)(6) 2018, THE PATIENT UNDERWENT A REVISION SURGERY. THE PATIENT HAD A TRAUMATIC INJURY LAST (B)(6) 2017 WITH SACRAL AND PELVIC FRACTURES. THE PATIENT HAD A BILATERAL LUMBOPELVIC SPINE CONSTRUCTION WITH SYNTHES USS FRACTURE AT L5-ILIUM (NO SCREWS IN SACRUM). THE PATIENT BROKE THE LEFT ROD JUST CRANIAL TO THE LEFT ILIAC SCREW ON AN UNKNOWN DATE. THE SURGEON THEN REMOVED ALL THE USS FRACTURE HARDWARE. THERE WERE NO OTHER HARDWARE ISSUES OTHER THAN THE BROKEN LEFT ROD. THE SURGEON RE-INSTRUMENTED THE PATIENT WITH SYNTHES USS SCREWS IN THE EXISTING SCREW HOLES AT L5 AND THE ILIUM WITH THE NEW RODS IN PLACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7971292 ↗