NA 04.161.032Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034733500), received between Sep 4, 2019 and Jan 12, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction 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. How this data works · Data updated Oct 13, 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.

• InjuryJan 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A OC2 FUSION ON AN UNKNOWN DATE. ABOUT TWO MONTHS AFTER SURGERY, IT WAS IDENTIFIED THAT THE ROD IN QUESTION MIGHT HAVE SLIPPED OFF THE PLATE IN QUESTION. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2023. THE CAUSE IS UNKNOWN. THE SURGEON COMMENTED THAT RE-OPERATION IS SCHEDULED INCLUDING CONFIRMATION OF SET SCREW, DUE TO THE POSSIBLE LOOSENING OF FUSION OF OCCIPITAL PLATE AND ROD ABOUT 2 MONTHS AFTER SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ROD ø3.5 PREBENT L240 TAN. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18504120 ↗
• InjuryJan 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A OC2 FUSION ON AN UNKNOWN DATE. ABOUT TWO MONTHS AFTER SURGERY, IT WAS IDENTIFIED THAT THE ROD IN QUESTION MIGHT HAVE SLIPPED OFF THE PLATE IN QUESTION. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2023. THE CAUSE IS UNKNOWN. THE SURGEON COMMENTED THAT RE-OPERATION IS SCHEDULED INCLUDING CONFIRMATION OF SET SCREW, DUE TO THE POSSIBLE LOOSENING OF FUSION OF OCCIPITAL PLATE AND ROD ABOUT 2 MONTHS AFTER SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ROD ø3.5 PREBENT L240 TAN. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18504114 ↗
• MalfunctionSep 4, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE TITANIUM (TI) PRE-BENT ROD WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8960496 ↗