Cervalign 66-DRIVER-SGRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810076561899), received between Dec 31, 2024 and Mar 16, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 2/18/2026. IT WAS REPORTED THAT DURING IMPLANT SCREW PLACEMENT, THE DISTAL TIPS OF TWO SYSTEM SCREWDRIVERS WERE BROKEN. THE FRACTURED INSTRUMENT TIPS WERE RECOVERED, AND THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT. AN ALTERNATIVE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENTS, WHICH WERE RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 2/24/2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606759 ↗
• MalfunctionMar 16, 2026Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 2/18/2026. IT WAS REPORTED THAT DURING IMPLANT SCREW PLACEMENT, THE DISTAL TIPS OF TWO SYSTEM SCREWDRIVERS WERE BROKEN. THE FRACTURED INSTRUMENT TIPS WERE RECOVERED, AND THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT. AN ALTERNATIVE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENTS, WHICH WERE RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 2/24/2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606318 ↗
• MalfunctionDec 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS MADE AWARE OF PRODUCT COMPLAINTS ON 11/20/2025. REPLACEMENTS WERE REQUESTED FOR FOUR SYSTEM SCREWDRIVERS THAT WOULD NOT FUNCTION AS INTENDED. IT WAS REPORTED THAT SOME OF THE SYSTEM SCREWDRIVERS WOULD NOT EFFECTIVELY ENGAGE AND RETAIN SYSTEM SCREWS, AND A COUPLE WITH BROKEN DISTAL TIPS. IT IS UNCLEAR HOW MANY INSTRUMENTS WERE NOT ENGAGING SCREWS, AND HOW MANY HAD BROKEN DISTAL TIPS. AN RMA NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT SCREWDRIVERS, WHICH AS OF 12/17/2025 WERE NOT RECEIVED AT THE MANUFACTURER FOR ASSESSMENT. REPEATED ATTEMPTS TO GATHER RELEVANT COMPLAINT INCIDENT DETAILS TO DETERMINE THE IMPACT TO PATIENT AND/OR PROCEDURE WERE UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 23832035 ↗
• MalfunctionJul 15, 2025Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 6/23/2025. IT WAS REPORTED THAT WHILE FINAL TIGHTENING A SYSTEM SCREW, THE DISTAL TIP OF A SYSTEM SCREWDRIVER WAS BROKEN AND REQUESTED TO BE REPLACED. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT, AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR THE RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 7/03/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22511843 ↗
• MalfunctionDec 31, 2024Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 11/25/2024. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER WAS IDENTIFIED AS HAVING MALFUNCTIONED AND WAS REQUESTED TO BE REPLACED. NO ADDITIONAL INFORMATION ON THE INSTRUMENT DEFICIENCY WAS PROVIDED. AN EMAIL INQUIRY WAS SENT TO THE COMPLAINT SOURCE TO BEST UNDERSTAND THE CONDITION OF THE RETURNED COMPLAINT DRIVER, AND FOR REGULATORY ASSESSMENT OF THE IMPACT TO THE PATIENT AND/OR PROCEDURE. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 12/09/2024.

  Patient problems: Insufficient Information

  MAUDE report 21049892 ↗