SynFrame 03.612.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034714509), received between May 25, 2017 and Apr 15, 2026 — 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.

• MalfunctionApr 15, 2026Compatibility Problem

  IT WAS REPORTED THAT THERE WAS A PRODUCT COMPATIBILITY ISSUE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886080 ↗
• InjuryMay 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PRIMARY SPINE SURGERY ON (B)(6) 2017, IT WAS NOT POSSIBLE TO INSERT THE FLEX-ARM INSIDE THE SYNFRAME GUIDING TUBE. ADDITIONALLY IT WAS NOT POSSIBLE TO LOCK THE FLEX-ARM. THE SURGEON HAD TO CHANGE HIS PROCEDURE AND THE PATIENT WAS NOT IMPLANTED WITH A CAGE. THE PATIENT MAY HAVE TO COME BACK FOR A NEW INTERVENTION. THE SURGERY WAS PROLONGED ABOUT FIFTEEN (15) MINUTES BUT THERE WAS NO PATIENT HARM. NO INFORMATION AVAILABLE ABOUT PATIENT OUTCOME AND CONDITION. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 6590370 ↗