NA 498.150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034789040), received between Nov 30, 2017 and Oct 28, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Compatibility Problem” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WAS DOING A 1 LEVEL INSTRUMENTED FUSION (L5-S1). WHEN SCREWING THE 4TH SCREW IN, THE SCREW WOULD NOT ADVANCE FURTHER, WITH 1/4 OF THE THREAD REMAINING. THE SCREW ALSO WOULD NOT BACK OUT. SURGEON TRIED TO USE PLIERS BUT THAT DID NOT WORK. THE SURGEON WAS ADVISED TO PUT ON THE HEAD AND SHORT ROD, AND LOCK THE CONSTRUCT OFF WITH SLEEVE AND NUTS SO THAT THIS WOULD TURN THE SCREW USING SCREW REMOVAL COUNTER TORQUE. THIS WORKED, AND SURGEON REMOVED THIS SET AND REPLACED IT WITH A NEW SET. THERE WAS A SURGICAL DELAY OF 10 MINUTES. THIS IS REPORT 4 OF 4 FOR (B)(4). THIS REPORT IS FOR A ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690879 ↗
• 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 AND (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 L

  Patient problems: Hypoesthesia; Pain; Weakness

  MAUDE report 7072268 ↗