NA 698335326Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034371078), received between Apr 1, 2019 and May 18, 2026 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 18, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIPS OF THE BENDER ATTACHMENTS WERE BENT OUT IF SHAPE AND DID NOT FUNCTION ADEQUATELY. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204200 ↗
• MalfunctionNov 14, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A SPINAL FUSION SURGERY, THE TIP OF THE INSTRUMENT WAS BENT, AND IT CHIPPED. THERE WAS NO DELAY, AND OTHER INSTRUMENTS WERE USED TO SUCCESSFULLY COMPLETE THE SURGERY. FRAGMENTS WERE EASILY REMOVED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684606 ↗
• MalfunctionApr 1, 2019Break; Break

  IT WAS REPORTED THAT DR. (B)(6) WAS PERFORMING A POSTERIOR SPINAL FUSION (SCOLIOSIS FUSION) ON A (B)(6) Y. OLD MALE PATIENT. WHILE DOING FINAL TIGHTENING THE X25 TORQUE DRIVE SHAFTS STRIPPED AT THE DISTAL END OF THE SHAFT. THIS IS PROBABLY DUE TO NORMAL WEAR AND TEAR, BOTH SHAFTS PRESENT IN THE SET NEED TO BE REPLACED. AS WELL, WHILE DR.(B)(6) WAS CORRECTING THE LORDOSIS OF THE SPINAL CURVE THROUGH THE ROD, ONE OF THE ATTACHMENT 10 DEGREE ANGLE PRONG BROKE OFF WHERE IT ATTACHES TO THE L BENDER. (THIS DEVICE IS A CUSTOM DEVICE AND I AM NOT CERTAIN IF IT IS REGISTERED WITH DEPUY SYNTHES, HOWEVER IT IS MADE BY DEPUY SYNTHES). THIS OCCURRED ON THE LEFT BENDER (698335318) AND THE ATTACHMENT PIECE IS (698335326). NOTHING FELL INTO THE PATIENT. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITHOUT DELAY AND WITHOUT COMPLICATIONS. I HAVE NOTHING FURTHER TO ADD TO THIS COMPLAINT. THE BROKEN SHAFTS WILL BE SENT VIA PUROLATOR (TRACKING: (B)(4). THE L BENDER AND THE ATTACHMENT ARE CURRENTLY NOT AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470798 ↗