NA 04.601.114Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034734323), received between Apr 13, 2021 and Dec 18, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical 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.

• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION (O-C4) ON (B)(6) 2023 THAT WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2023 THE PATIENT CAME TO THE OUTPATIENT CLINIC, WHERE IT WAS DISCOVERED THAT THE TWO SCREWS IN QUESTION HAD LOOSENED FROM THE OCCIPITAL BONE. REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2023 TO REPLACE THE OCCIPITAL BONE PLATE AND THE BONE SCREWS IN QUESTION. THE CAUSE OF THE LOOSENING IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.5MM TI OCCIPITAL SCREW 14MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18346011 ↗
• InjuryApr 13, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT¿S ROD BROKE, AND A SCREW WAS LOOSE. IN (B)(6) 2018 A POSTERIOR CERVICAL FUSION WAS PERFORMED ON THE PATIENT AT O-C4. ON AN UNKNOWN DATE, THE PATIENT TURNED OVER IN BED AND HEARD CRACKING NOISE FROM THE CERVICAL AREA. ON (B)(6) 2021 THE PATIENT WENT TO SEE THE SURGEON, AND IT WAS FOUND BY CT, THAT THE ROD HAD BROKEN OFF AND THE SCREW WAS LOOSE. THE PATIENT HAS SUFFERED FROM PARALYSIS IN THE LIMBS SINCE THE EVENT. ON (B)(6) 2021 THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE FOR ROD REPLACEMENT AND SCREW-APPLICATION-RANGE EXTENSION. THE SURGEON EVALUATED THE EVENT¿S SEVERITY AS ¿MILD TO MODERATE.¿ THIS REPORT INVOLVES ONE (1) 4.5MM TI OCCIPITAL SCREW 14MM. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11656997 ↗