NA 03.161.026Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034711607), received between Sep 9, 2019 and Sep 9, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Cut” (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.

• InjurySep 9, 2019Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE OCCIPITO SYNAPSE SYSTEM WAS USED FOR A SURGICAL PROCEDURE FOR CERVICAL OCCIPITO FIXATION ON (B)(6) 2019. THERE WERE NO INCONVENIENCES FOR CERVICAL FIXATION. HOWEVER, AT THE TIME OF PERFORMING OCCIPUCIO FIXATION, THROUGH PROPER AND REVIEWED TECHNIQUE BY THE MEDICAL TEAM, IT WAS NOT POSSIBLE TO CARRY OUT THE FIXATION. THE SCREWS WERE NOT FIXED, PROBABLY DUE TO LACK OF EDGE OF THE MALE USED. IT WAS NECESSARY TO PERFORM 11 PERFORATIONS IN THE PATIENT'S SKULL, WITHOUT ACHIEVING SUCCESS WITH THE TECHNIQUE DESCRIBED. AN ADEQUATE PERFORATION IS NOT ACHIEVED, MAKING THE PLACEMENT OF THE OCCIPITAL SCREWS IMPOSSIBLE. SURGEON ALSO TRIED WITH THE MALE IN CARDAN BUT THE PROCEDURE WAS ALSO NOT SUCCESSFUL, BECAUSE THE DOCTOR DOES NOT ACCOMMODATE THE ANGLE OF THE INSTRUMENTS. FINALLY, THE SURGEON USED SCREWS OF LESS DIAMETER, ACHIEVED ADEQUATE DRILLING TO FINALIZE THE FIXATION. THE SURGERY LASTED APPROXIMATELY 10 HOURS. THIS PROCEDURE DOES NOT LAST MORE THAN 5 HOURS. PATIENT OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN OCCIPITAL PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UN

  Patient problems: Injury; No Code Available

  MAUDE report 8975084 ↗