NA 487.966Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587055848), received between Jun 12, 2017 and Jun 12, 2017 — classified as 1 injury.

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.

• InjuryJun 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY TO EXTEND THE REPORTED DEVICE DURING A MANDIBULAR EXTENSION SURGERY ON (B)(6) 2017. THE SURGEON CONFIRMED THE EXTENSION LENGTH INDICATOR SHOWED 1 MM. HOWEVER, THE EXTENDED ACTUAL MEASURED LENGTH WAS 5 MM. THE SURGEON COMMENTED THAT THE SURGERY WAS SOMEHOW COMPLETED. THE CUSTOMER UNDERSTOOD HOW THE DEVICE WORKS AND HOW TO USE IT FOR THE UPCOMING SURGERIES, SO THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. THERE WAS NO SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 6635690 ↗