NA 498.650Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034791302), received between Nov 30, 2017 and Jul 29, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 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.

• InjuryJul 29, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO TWO (2) BROKEN TITANIUM (TI) SIDE-OPENING SCREWS ON (B)(6) 2019. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH THE T12-L2 POSTERIOR UNIVERSAL SPINE SYSTEM (USS) CONSTRUCT WITH NO SCREWS AT L1 FOR AN L1 TRAUMATIC BURST FRACTURE IN NOVEMBER 2017. ON AN UNKNOWN DATE AFTER THE IMPLANTATION SURGERY, THE PATIENT HAD A NON-UNION AND THE T12 USS SCREWS BROKE OFF JUST BELOW THE HEAD BILATERALLY. THE SURGEON REMOVED ALL FOUR SCREWS AND TWO RODS INCLUDING THE TWO BROKEN SCREWS IN THE T12 LEVEL. THE SURGEON THEN PLACED A NEW T10-L3 USS CONSTRUCT WITH NO SCREWS AT L1 EXTENDING TO CRANIAL AND CAUDAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN USS SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# 2). UNKNOWN USS RODS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# 2). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 8837221 ↗
• InjuryJul 29, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO TWO (2) BROKEN TITANIUM (TI) SIDE-OPENING SCREWS ON (B)(6) 2019. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH THE T12-L2 POSTERIOR UNIVERSAL SPINE SYSTEM (USS) CONSTRUCT WITH NO SCREWS AT L1 FOR AN L1 TRAUMATIC BURST FRACTURE IN (B)(6) 2017. ON AN UNKNOWN DATE AFTER THE IMPLANTATION SURGERY, THE PATIENT HAD A NON-UNION AND THE T12 USS SCREWS BROKE OFF JUST BELOW THE HEAD BILATERALLY. THE SURGEON REMOVED ALL FOUR SCREWS AND TWO RODS INCLUDING THE TWO BROKEN SCREWS IN THE T12 LEVEL. THE SURGEON THEN PLACED A NEW T10-L3 USS CONSTRUCT WITH NO SCREWS AT L1 EXTENDING TO CRANIAL AND CAUDAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN USS SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 2). UNKNOWN USS RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 2). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 8837197 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A SPINAL FUSION ON (B)(6) 2002 DUE TO SPONDYLOLYTIC SPONDYLOLISTHESIS AND LUMBOSACRAL NEURITIS AND UNDERWENT AN ANTERIOR AND POSTERIOR SPINAL FUSION WITH INSTRUMENTATION AND AUTOGENOUS BONE GRAFT ALONG WITH A FEMORAL RING ALLOGRAFT AND A GILL TYPE PROCEDURE. IMPLANTS INCLUDED UNIVERSAL SPINE SYSTEM (USS); THREE (3) 45MM SIDE-OPENING SCREWS, ONE (1) 50MM SIDE-OPENING SCREW, FOUR (4) 11MM NUTS, FOUR (4) COLLAR WITH GROOVES AND TWO (2) 6.0MM RODS. OTHER IMPLANTS INCLUDED; ONE (1) FRA BONE GRAFT, SIZE 5, ONE (1) CERVICAL SPINE LOCKING PLATE 34MM, FOUR (4) 4.35MM EXPANSION HEAD SCREWS 25MM AND FOUR (4) 1.8MM LOCKING SCREWS. PATIENT WAS IMPROVING AND HARDWARE WAS IN PLACE IN (B)(6) 2003. ON (B)(6) 2003, A CAT SCAN WAS PERFORMED ON THE LUMBAR SPINE AND DEGENERATIVE CHANGES WERE NOTED. THE PATIENT RETURNED TO HOSPITAL ON (B)(6) 2003 DUE TO SPONDYLOLISTHESIS, PAIN, NUMBNESS AND SWELLING IN BOTH LEGS AND HAD DISCOGRAM INJECTIONS TO THE LUMBAR SPINE. ON (B)(6) 2003, THE PATIENT INJURED HIS LOWER BACK AT WORK AND RETURNED TO THE HOSPITAL ON (B)(6) 2003 FOR BACK PAIN AND SPONDYLOLISTHESIS. ON (B)(6) 2004, THE PATIENT UNDERWENT A REVISION AT L5-S1 DUE TO LOW

  Patient problems: Hypoesthesia; Pain; Weakness

  MAUDE report 7071565 ↗