SynFrame 387.356Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034771151), received between Apr 19, 2021 and Jan 9, 2025 — classified as 2 malfunctions.

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 18, 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.

• MalfunctionJan 9, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 , THE NURSE WAS SETTING UP THE SYNFRAME AND NOTICED THAT TWO (2) SYNFRAME RINGS HAD STRIPPED SCREWS, MAKING IT DIFFICULT TO ASSEMBLE TO SYNFRAME RING. ALSO, THE SURGEON BROKE THE ROD GUIDE FOR THE SYNFRAME HOMAN BLADE. FRAGMENTS THAT WERE GENERATED WERE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113421 ↗
• MalfunctionApr 19, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT FOR A SURGERY FOR ANTERIOR LUMBAR INTERBODY FUSION. DURING THE SURGERY, NORMALLY USING OF THE HOLDER FOR BONE LEVER WAS BROKE. THERE WAS NO FRAGMENT GENERATED. THE SURGERY COMPLETED SUCCESSFULLY WITH 01 (ONE) MINUTE DELAY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED.THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) HOLDER FOR SYNFRAME BONE LEVERS. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11690822 ↗