Salvo® Spine System 11-6401Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10840642163704), received between Sep 23, 2022 and Jul 21, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Separation Failure” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  APPROXIMATELY SIX MONTHS POST-OPERATIVELY PATIENT REPORTED PAIN FOLLOWING A PATIENT FALL APPROXIMATELY 3 MONTHS POST-OPERATIVELY; ON RADIOGRAPH, ONE LOCKING SCREW WAS OBSERVED TO BE DISENGAGED FROM A PEDICLE SCREW IN THE PEDICLE SCREW CONSTRUCT. A PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE SUBJECT DEVICE.

  Patient problems: Pain

  MAUDE report 22560860 ↗
• InjuryAug 17, 2023Separation Failure; Separation Failure

  AT APPROXIMATELY 13 MONTHS POST-OPERATIVELY, A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE LOOSE LOCKING SCREWS IN A MULTI-LEVEL PEDICLE SCREW CONSTRUCT.

  Patient problems: Failure of Implant

  MAUDE report 17568633 ↗
• InjuryJul 25, 2023Separation Failure; Separation Failure

  AT APPROXIMATELY EIGHTEEN MONTHS POST-OPERATIVELY, A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE A DISENGAGED LOCKING SCREW.

  Patient problems: Failure of Implant

  MAUDE report 17392508 ↗
• InjuryJul 6, 2023Separation Failure; Separation Failure

  AT APPROXIMATELY NINE MONTHS POST-OPERATIVELY, A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE LOOSE LOCKING SCREWS THAT HAD DISASSOCIATED FROM A MULTI-LEVEL PEDICLE SCREW REVISION CONSTRUCT EXTENSION. FOUR LOCKING SCREWS AND TWO CONNECTORS WERE REMOVED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17274018 ↗
• InjuryOct 13, 2022Separation Failure; Separation Failure

  AT APPROXIMATELY TWO MONTHS POST-OPERATIVELY, A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE A LOOSE LOCKING SCREW THAT HAD DISASSOCIATED FROM AN OFFSET CONNECTOR IN A PEDICLE SCREW CONSTRUCT. ONE LOCKING SCREW AND ONE CONNECTOR WERE REMOVED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15597953 ↗
• InjurySep 23, 2022Separation Failure; Separation Failure

  AT AN UNSPECIFIED TIME POST-OPERATIVELY, A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE LOCKING SCREWS THAT HAD DISSOCIATED FROM THE SCREW HEADS IN A MULTI-LEVEL CERVICO-THORACIC CONSTRUCT. ADDITIONAL HARDWARE WAS REMOVED AND REPLACED AT THAT TIME.

  Patient problems: Failure of Implant

  MAUDE report 15473427 ↗