CSLP 324.067Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034769202), received between May 15, 2019 and Apr 24, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Material Integrity Problem

  IT WAS REPORTED THAT TEETH OF THE DEVICE WERE BROKEN OFF AT THE TIP DURING USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988586 ↗
• MalfunctionJan 11, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE COUNTERTORQUE WRENCHES FOR CERVICAL SPINE LOCKING PLATE (CSLP) WERE DAMAGED DURING THE REMOVAL SURGERY. PRONGS WERE BROKEN OFF AND BENT DURING CASE. FRAGMENTS WERE GENERATED BUT THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR (1) COUNTERTORQUE WRENCH FOR CSLP. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13231496 ↗
• MalfunctionJan 11, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE COUNTERTORQUE WRENCHES FOR CERVICAL SPINE LOCKING PLATE (CSLP) WERE DAMAGED DURING THE REMOVAL SURGERY. PRONGS WERE BROKEN OFF AND BENT DURING CASE. FRAGMENTS WERE GENERATED BUT THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR (1) COUNTERTORQUE WRENCH FOR CSLP. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13231261 ↗
• MalfunctionOct 19, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE CSLP COUNTER TORQUE WRENCH HANDLE FOUR-PRONG INSTRUMENT BROKE A PRONG OFF DURING THE SCREW EXTRACTION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) COUNTERTORQUE WRENCH FOR CSLP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12660733 ↗
• MalfunctionJun 15, 2021Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE BATTERY POWERED DRIVER BECAME STUCK IN THE FORWARD MOTION, UNABLE TO BE SHUT OFF. ONE OF THE PRONGS ON THE TIP WERE MISSING FROM THE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) COUNTER TORQUE WRENCH FOR CSLP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999616 ↗
• MalfunctionJun 27, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE DURING CLEANING AT MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) THE TIP OF COUNTERTORQUE WRENCH ARE BENT AND CAN NOT BE USED ANYMORE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) COUNTERTORQUE WRENCH FOR CSLP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8741193 ↗
• MalfunctionMay 15, 2019Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL FUSION ON (B)(6) 2019, THE SURGEON WAS PLACING A CERVICAL SPINE LOCKING PLATE (CSLP) LOCKING SCREW WITH THE CSLP COUNTER TORQUE AND ONE OF THE PRONGS BROKE OFF THE COUNTER TORQUE. THEY PULLED ANOTHER SET AND USED THE COUNTER TORQUE IN THAT SET TO FINISH. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE BUT WERE EASILY REMOVED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: CSLP LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A COUNTERTORQUE WRENCH FOR CSLP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8611502 ↗