CSLP 03.610.601Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034713663), received between Dec 27, 2016 and Aug 6, 2021 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING THE PROCEDURE AS THE SURGEON WAS INSERTING AND TIGHTENING, ONE OF THE TEETH SHEARED OFF THE DRIVER. A FRAGMENT WAS GENERATED AND WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE INSTRUMENT. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) LOCKING DRIVER FOR CSLP QUICK LOCK SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288550 ↗
• MalfunctionDec 27, 2016Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF TWO OF THE SELF-RETAINING SCREWDRIVERS FOR QUICK LOCK SCREWS ARE DEFORMED. THE TIP OF ONE LOCKING DRIVER FOR CSLP QUICK LOCK SCREWS WAS ALSO DEFORMED. ANOTHER LOCKING DRIVER FOR CSLP QUICK LOCK SCREWS WAS MISSING TWO PIECES. ALL FOUR DEVICES WERE FOUND IN THE STERILE PROCESSING ROOM DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. WHEN THE DEVICES WERE RECEIVED BY THE MANUFACTURER IT WAS NOTED THAT ALL THE DEVICES WERE FOUND TO HAVE BROKEN TIPS. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6206250 ↗
• MalfunctionDec 27, 2016Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF TWO OF THE SELF-RETAINING SCREWDRIVERS FOR QUICK LOCK SCREWS ARE DEFORMED. THE TIP OF ONE LOCKING DRIVER FOR CSLP QUICK LOCK SCREWS WAS ALSO DEFORMED. ANOTHER LOCKING DRIVER FOR CSLP QUICK LOCK SCREWS WAS MISSING TWO PIECES. ALL FOUR DEVICES WERE FOUND IN THE STERILE PROCESSING ROOM DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. WHEN THE DEVICES WERE RECEIVED BY THE MANUFACTURER IT WAS NOTED THAT ALL THE DEVICES WERE FOUND TO HAVE BROKEN TIPS. THIS IS REPORT 3 OF 4 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6206223 ↗