NA 388.112Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034771915), received between Feb 21, 2017 and Sep 6, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionSep 6, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE IN SITU BENDER TIP SNAPPED WHILE ROD BENDING DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT INVOLVES ONE IN SITU BENDER-RIGHT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363710 ↗
• MalfunctionSep 6, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE INSITUBENDER TIP SNAPPED WHILE ROD BENDING DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT INVOLVES ONE IN SITU BENDER-RIGHT. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363677 ↗
• MalfunctionFeb 21, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, DURING AN INITIAL THORACOLUMBAR SPINAL FUSION SURGERY, THE TIP OF THE IN SITU BENDER-RIGHT BROKE OFF. WHILE PUTTING IN A 6.0MM HEX-END ROD 500MM, THE SURGEON USED A PAIR OF IN SITU BENDERS FROM THE USS SYSTEM TO BEND THE ROD IN SITU. WHILE DOING THIS, THE TIP OF ONE OF THE BENDERS BROKE OFF. THE PIECE WAS EASILY RETRIEVED FROM THE PATIENT. THERE WAS NO DELAY IN THE CASE AND NO HARM TO THE PATIENT. CONCOMITANT DEVICES REPORTED: 6.0MM HEX-END ROD 500MM (PART # 09.633.501, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6347641 ↗