NA 498.774Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034791708), received between Feb 10, 2020 and Feb 10, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION THAT HAD AN L-3 ILIUM POSTERIOR SPINAL FUSION WITH SYNTHES USS WHICH WAS IMPLANTED ON (B)(6) 2016. ON AN UNKNOWN DATE, THE PATIENT HAD AN ADJACENT LEVEL DISC DISEASE AND STENOSIS ABOVE THE FUSION AT L-2 AND L-3. THE PATIENT ALSO BROKE THE RIGHT ILIAC SCREW ON AN UNKNOWN DATE. DURING THE REVISION PROCEDURE, THE SURGEON REMOVED BOTH OF THE RODS. HE THEN REMOVED BOTH ILIAC SCREWS AND SAID THAT HE WOULD NOT REPLACE THEM AND FELT THAT THE PATIENT DID NOT NEED THE ILIAC SCREWS. THE BROKEN PART OF THE RIGHT ILIAC SCREW REMAINS IN THE PATIENT. HE THEN TESTED TO SEE IF ANY OF THE SCREWS FROM L3-S1 WERE LOOSE. THERE WERE TWO (2) LOOSE SCREWS THAT WERE REPLACED. HE REPLACED TWO (2) SCREWS AND REPLACED THEM WITH LARGER DIAMETER USS SCREWS. THE LOCATION AND SIZE OF THESE SCREWS IS UNKNOWN. THE SURGEON THEN PLACED NEW SCREWS AT L2. HE THEN DID THE DECOMPRESSION OF THE LEVEL ABOVE THE PREVIOUS FUSION AT L2-L3. HE THEN PLACED NEW RODS AND CONNECTED THEM TO THE SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY ISSUES. PATIENT WAS STABLE AFTER THE PROCEDURE. THIS REPORT IS FOR ONE (1) 7.0 MM TI SIDE-OPENING

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9688317 ↗