NA 498.102Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034788838), received between Nov 30, 2017 and May 28, 2021 — classified as 3 injuries.

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

• InjuryMay 28, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A REMOVAL SURGERY FOR BILATERAL BROKEN RODS ON A POSTERIOR SPINAL FUSION THAT WAS SYNTHES SPINE USS. THE PREVIOUS SURGERY DATE WAS (B)(6) 2018. SURGEON DISCOVERED THAT RODS WERE BROKE FOR AN UNKNOWN REASON AT AN UNKNOWN TIME. DURING THE REVISION, THE SURGEON REMOVED ALL THE SYNTHES USS HARDWARE THAT WAS PLACED AT L4-L5. THE PATIENT HAD NON UNION AT THE L4-L5 LEVEL AND SURGEON PLACED NEW SYNTHES USS HARDWARE. PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) . THIS REPORT IS FOR ONE (1) 6.0MM TI HARD ROD 50MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11903302 ↗
• InjuryMay 28, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A REMOVAL SURGERY FOR BILATERAL BROKEN RODS ON A POSTERIOR SPINAL FUSION THAT WAS SYNTHES SPINE USS. THE PREVIOUS SURGERY DATE WAS (B)(6) 2018. SURGEON DISCOVERED THAT RODS WERE BROKE FOR AN UNKNOWN REASON AT AN UNKNOWN TIME. DURING THE REVISION, THE SURGEON REMOVED ALL THE SYNTHES USS HARDWARE THAT WAS PLACED AT L4-L5. THE PATIENT HAD NON UNION AT THE L4-L5 LEVEL AND SURGEON PLACED NEW SYNTHES USS HARDWARE. PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 6.0MM TI HARD ROD 50MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11903249 ↗
• 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 EXPANSIONHEAD 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 LOWE

  Patient problems: Hypoesthesia; Pain; Weakness

  MAUDE report 7072374 ↗