NA 698335332Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034371115), received between Apr 1, 2019 and Apr 1, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2019Break; Break

  IT WAS REPORTED THAT DR. (B)(6) WAS PERFORMING A POSTERIOR SPINAL FUSION (SCOLIOSIS FUSION) ON A (B)(6) 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 ((B)(4)) AND THE ATTACHMENT PIECE IS ((B)(4)). 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 (B)(6). THE L BENDER AND THE ATTACHMENT ARE CURRENTLY NOT AVAILABLE FOR RETURN. CUSTOMER REFERENCE/PO/SERVICE: (B)(4). WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470458 ↗