NA 387.286Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034770994), received between Jan 16, 2017 and Jan 31, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TOOTH OF A DRILL GUIDE IN THE CERVICAL SPINE LOCKING PLATE (CSLP) SET HAD BROKEN OFF; DRILL GUIDE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A SINGLE LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619086 ↗
• MalfunctionOct 1, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, WHILE INSPECTING THE SINGLE LOCKING DRILL GUIDE, THE TECHNICIAN NOTED THE TIP HAD BROKEN COMPONENT. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR A SINGLE LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565215 ↗
• MalfunctionJun 25, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SELF-HOLDING DRILL SLEEVE WAS BENT AND UNABLE TO ALLOW FULL PASSAGE OF THE DRILL BIT. IT IS UNKNOWN IF WHEN THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SINGLE LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8732742 ↗
• MalfunctionAug 30, 2018Break; Component Missing; Break; Component Missing

  IT WAS REPORTED ON (B)(6) 2018 THAT A SINGLE LOCKING DRILL GUIDE IS MISSING A SET SCREW DURING A ROUTINE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SINGLE LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7832862 ↗
• MalfunctionFeb 8, 2018Break; Break

  IT WAS REPORTED THAT WHILE INSPECTING THE DRILL GUIDE IN CENTRAL STERILE, IT WAS DISCOVERED THAT ONE OF THE FLANGES WAS BROKEN. PART WAS NOT USED IN SURGERY. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) SINGLE LOCKING DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7251251 ↗
• MalfunctionJan 16, 2017Corroded; Material Fragmentation; Component Missing; Corroded; Material Fragmentation; Component Missing

  DEVICE REPORT FROM SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS INITIALLY REPORTED THAT RUST WAS DETECTED ON THE SURFACE AT THE TIP OF A DRILL SLEEVE DURING CLEANING PROCESS. THERE WAS NO REPORTED PATIENT OR PROCEDURAL INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. UPON INITIAL INSPECTION OF THE RETURNED DEVICE ON DECEMBER 23, 2016 IT WAS OBSERVED THAT A SMALL PORTION OF THE TONGS WAS BROKEN OFF AND MISSING. IT IS UNKNOWN WHEN THE REPORTED ISSUES OCCURRED. THIS EVENT WAS REASSESSED FOR REPORTABILITY BASED ON THIS ADDITIONAL FINDING. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6253359 ↗