NA 388.329Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034772424), received between Jul 12, 2018 and Oct 15, 2019 — classified as 2 malfunctions.

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

• MalfunctionOct 15, 2019Break; Break

  UPDATED EVENT DESCRIPTION: DEVICE REPORT FROM PERU REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A LUMBAR ARTHRODESIS REVIEW S1 REVISION PROCEDURE ON (B)(6) 2019 THE SURGEON WAS UNABLE TO ADJUST THE TWO (2) LOCKING CAPS AND COULD NOT INSERT THE TWO (2) CROSS-LINK CLAMPS. DURING SURGERY THE TWO SCREWDRIVERS BROKE. THERE WAS A SURGICAL DELAY OF TEN TO FIFTEEN (10-15) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS STABLE. THIS REPORT CAPTURES INOPERATIVE ISSUE OF BROKEN SCREWDRIVERS, WHILE RELATED COMPLAINT (B)(4) CAPTURES THE INTRAOPERATIVE ISSUE OF UNABLE TO ADJUST THE TWO (2) LOCKING CAPS AND COULD NOT INSERT THE TWO (2) CROSS-LINK CLAMPS. CONCOMITANT DEVICES: CLICKX LOCKCAP (PART# 498.570, LOT# UNKNOWN, QUANTITY UNKNOWN) CROSS-LINK-CLAMP FOR ROD (PART# 498.813, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 3.5MM HEX SCREWDRIVER SHAFT 6MM HXC-LONG. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9193544 ↗
• MalfunctionJul 12, 2018Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, TWO (2) HEXAGONAL SCREWDRIVER SHAFTS WERE DEFECTIVE. THE TWO SCREWDRIVERS DUSTED ONE OF THE LAST SCREWS THAT THE SURGEON WAS IMPLANTING. THERE WAS A SURGICAL DELAY FOR ABOUT TWO (2) HOURS. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 3.5MM HEX SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7683518 ↗