EXPEDIUM ALTALYNE VIPER 1797-96-601SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034566399), received between Sep 9, 2024 and Dec 13, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024 THE ALTALYNE ROD DID NOT SEEM TO HAVE THE SAME STIFFNESS CHARACTERISTICS AND AS A NORMAL ALTALYNE ROD HAS. DOCTOR FELT LIKE IT BENT MUCH EASIER THAN NORMAL WHEN CONTOURING. UPON MANUFACTURED INVESTIGATION THE DEVICE WAS FOUND TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924659 ↗
• MalfunctionSep 9, 2024Device Slipped; Device Slipped

  IT WAS REPORTED BY SURGEON THAT THIS WAS THE THIRD TIME POST-OPERATIVELY THE ROD HAS SLIPPED AT THE DISTAL END OF THE CONSTRUCT USING THE EXPEDIUM 5.5 UNI SCREWS. SET SCREWS HAVE ALWAYS BEEN FINAL TIGHTENED TO EITHER 80 INCH POUNDS OR 100 INCH POUNDS. THE SLIPPING HAS BEEN NOTICED AT THE POST OP X-RAY FILMS MONTHS AFTER PROCEDURE. THIS REPORT IS FOR ONE (1) ALTALYNE ULTRA AS 5.5 X 600MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4) (B)(4) - CAPTURES THE 1ST EVENT. (B)(4) - CAPTURES THE 2ND EVENT. (B)(4)- CAPTURES THE 3RD EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20177431 ↗
• MalfunctionSep 9, 2024Device Slipped; Device Slipped

  IT WAS REPORTED BY SURGEON THAT THIS WAS THE THIRD TIME POST-OPERATIVELY THE ROD HAS SLIPPED AT THE DISTAL END OF THE CONSTRUCT USING THE EXPEDIUM 5.5 UNI SCREWS. SET SCREWS HAVE ALWAYS BEEN FINAL TIGHTENED TO EITHER 80 INCH POUNDS OR 100 INCH POUNDS. THE SLIPPING HAS BEEN NOTICED AT THE POST OP X-RAY FILMS MONTHS AFTER PROCEDURE. THIS REPORT IS FOR ONE (1) ALTALYNE ULTRA AS 5.5 X 600MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). (B)(4) - CAPTURES THE 1ST EVENT. (B)(4) - CAPTURES THE 2ND EVENT. (B)(4) - CAPTURES THE 3RD EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20177390 ↗
• MalfunctionSep 9, 2024Device Slipped; Device Slipped

  IT WAS REPORTED BY SURGEON THAT THIS WAS THE THIRD TIME POST-OPERATIVELY THE ROD HAS SLIPPED AT THE DISTAL END OF THE CONSTRUCT USING THE EXPEDIUM 5.5 UNI SCREWS. SET SCREWS HAVE ALWAYS BEEN FINAL TIGHTENED TO EITHER 80 INCH POUNDS OR 100 INCH POUNDS. THE SLIPPING HAS BEEN NOTICED AT THE POST OP X-RAY FILMS MONTHS AFTER PROCEDURE. THIS REPORT IS FOR ONE (1) ALTALYNE ULTRA AS 5.5 X 600MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). (B)(4). CAPTURES THE 3RD EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20172317 ↗