NA 03.614.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034714936), received between Feb 21, 2017 and Sep 25, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionSep 25, 2019Break; Break

  THE FLAT SPRING BAR BROKE OFF DURING ROD BENDING. NOTHING FEEL IN THE PATIENT AS THIS PART WAS DONE ON THE SIDE OVER A STERILE TABLE. THE INSTRUMENT IS AVAILABLE FOR RETURN, BUT THE BROKEN PIECE WAS DISCARDED BY HOSPITAL PERSONNEL. THERE IS NO SURGICAL DELAY ARE REPORTED. THERE WAS NO PATIENT INVOLVEMENT. DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COUNTRY AS FOLLOWS: (B)(6).                                                                                                      CONCOMITANT DEVICES REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119642 ↗
• MalfunctionFeb 21, 2017Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTED THAT DURING AN UNKNOWN CERVICAL SPINE PROCEDURE ON (B)(6) 2017, WHILE THE SURGEON WAS USING A SYNTHES ROD BENDER, A PIECE OF THE BENDER BROKE OFF. THERE WAS REPORTEDLY A FIVE MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR/LIKE PRODUCT. CONCOMITANT DEVICES REPORTED: UNKNOWN SYNTHES ROD (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6345991 ↗