ALTALYNE 5161-04-1700Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034565989), received between Mar 7, 2024 and Jul 21, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE RIVOT BROKE ON THE CENTER PORTION OF THE BENDER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556318 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THE SURGEON WAS USING ROD BENDER INSTRUMENT, AND AS SURGEON WAS ADJUSTING BENDING DIAMETER, WORKING JOINT OF BENDER FELL APART (APPEARS THAT BOLD FRACTURED, UNSURE OF WHEN FRACTURE MAY HAVE HAPPENED) AND ENTIRE BENDING INSTRUMENT DISASSEMBLED. NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED BY OPENING ANOTHER TRAY TO USE A DIFFERENT ROD BENDING INSTRUMENT. FRAGMENTS WERE GENERATED BUT WERE EASILY REMOVED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327744 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT THE FRENCH BENDER CENTER PORTION BROKEN. CORONAL BENDERS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892537 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT THE FRENCH BENDER CENTER PORTION BROKEN. CORONAL BENDERS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891603 ↗
• MalfunctionJan 21, 2025Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT NO FRAGMENTS WERE RETAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21198965 ↗
• MalfunctionJan 8, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT NO FRAGMENTS WERE GENERATED AND THERE WAS NO SURGICAL DELAY. THIS WAS AN INTRAOPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103192 ↗
• MalfunctionMar 15, 2024Break; Break

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024, WHILE BENDING AN ALTALYNE ROD, THE CENTER PIECE FRENCH ROD BENDER HOLDING THE ROD BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. CONCOMITANT DEVICE: UNKNOWN ROD (UNKNOWN PART/LOT). THIS REPORT IS FOR ONE FRENCH ROD BENDER FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912546 ↗
• MalfunctionMar 7, 2024Break; Break

  IT WAS REPORTED THAT ON FEBRUARY 20, 2024 THE INSTRUMENT BROKE. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES. THERE WAS NO GENERATION OF FRAGMENTS. THIS REPORT IS FOR ONE FRENCH ROD BENDER FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861194 ↗