NA 04.614.516Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034739304), received between Mar 13, 2020 and Jun 22, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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.

• InjuryJun 22, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT THE PRIMARY PROCEDURE. TRANSVERSE CONNECTORS WERE IMPLANTED. ON (B)(6) 2022 A REMOVAL PROCEDURE WAS PERFORMED. WHEN EITHER 04.614.515S (LOT # H726297) OR 04.614.516S (LOT # H715939) WAS REMOVED DURING THE PROCEDURE, THE CONNECTOR AND A SETSCREW STUCK TOGETHER, AND THE SURGEON HAD DIFFICULTY IN DETACHING THEM. THEN, THE CONNECTING AREA ON THE CONNECTOR BROKE. A FRAGMENT WAS REMOVED FROM THE LESION, AND THE PROCEDURE WAS COMPLETED MORE THAN 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - LOCKING/SET SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE TI TOPLOADING TRANSCONNECTOR MED-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 14778060 ↗
• MalfunctionMar 13, 2020Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS PERFORMING C2-6 POSTERIOR CERVICAL FUSION PROCEDURE USING THE 4.0 SYNAPSE SYSTEM. NEAR THE END OF THE CASE, AFTER THE SURGEON APPLIED TWO TRANSCONNECTOR LOCKING SET SCREWS AND EIGHT (8) TITANIUM LOCKING SCREWS TO THE REMAINING SCREWS, THE DOCTOR THEN FINALLY TIGHTENED ALL TEN (10) SET SCREWS. THE PHYSICIAN ATTEMPTED TO SEAT A MEDIUM SYNAPSE TOP LOADING TRANSCONNECTOR TO THE TRANSCONNECTOR SET SCREWS. HE THEN APPLIED A 7.5MM TRANSCONNECTOR LOCKING NUT TO THE LEFT SIDE OF THE TRANSCONNECTOR BUT WHEN HE ATTEMPTED TO APPLY AND SEAT THE RIGHT SIDE THE TRANSCONNECTOR WOULD NOT SEAT. HE LOOSENED THE NUT ON THE LEFT SIDE TO SEE IF THAT WOULD HELP, BUT IT WOULD NOT SEAT. HE TRIED THIS A NUMBER OF TIMES, BUT IT CLEARLY WOULDN¿T SEAT PROPERLY. THEY USED MEDIUM ANGLED TOP LOADING TRANSCONNECTOR BUT HAD THE SAME RESULT. WHEN HE WAS REMOVING THE 7.5MM BUT IT WOULD NOT RELEASE AND HE SAID IT FELT AS IF THE HEAD OF THE PEDICLE SCREW SPLAYED OPEN. HE DECIDED TO REMOVE THE TRANSCONNECTOR NUTS, LOCKING SCREWS AND THE TRANSCONNECTOR AND SIMPLY USE JUST THE STANDARD TITANIUM LOCKING SCREWS. HE WANTS TO KNOW WHY THE TRANSCONNECTOR WOULD NOT SEAT AND I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832540 ↗