Proficient™ Posterior Cervical Spine System 11-8999Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10840642111217), received between Dec 19, 2017 and Jul 16, 2024 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  APPROXIMATELY ONE MONTH POST-OPERATIVELY, A PROCEDURE WAS PERFORMED TO REMOVE A SINGLE LOOSE LOCKING SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19755856 ↗
• MalfunctionApr 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AT AN UNSPECIFIED TIME POST-OPERATIVELY, DURING AN UNRELATED SURGICAL PROCEDURE TWO LOOSE LOCKING SCREWS WERE IDENTIFIED AND REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164330 ↗
• MalfunctionAug 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AT APPROXIMATELY 8 WEEKS POST-OPERATIVELY, A LOOSE LOCKING SCREW AND SPINAL ROD IN A PEDICLE SCREW CONSTRUCT WERE IDENTIFIED. NO INTERVENTION HAS BEEN TAKEN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17500369 ↗
• MalfunctionAug 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AT AN UNSPECIFIED TIME POST-OPERATIVELY, A LOOSE LOCKING SCREW IN A PEDICLE SCREW CONSTRUCT WAS IDENTIFIED. NO INTERVENTION HAS BEEN TAKEN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17500300 ↗
• InjuryJun 3, 2022Disconnection

  AFTER APPROXIMATELY 5 MONTHS 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.

  Patient problems: Failure of Implant

  MAUDE report 14594654 ↗
• InjuryMar 2, 2021Material Separation

  AT APPROXIMATELY THREE YEARS POST-OPERATIVELY, A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE LOCKING SCREWS THAT HAD DISSOCIATED FROM THE SCREW HEAD IN A MULTI-LEVEL CERVICO-THORACIC CONSTRUCT.

  Patient problems: Insufficient Information

  MAUDE report 11401574 ↗
• InjuryFeb 19, 2020Loose or Intermittent Connection

  APPROXIMATELY 4 WEEKS POST-OPERATIVELY, THE SURGEON NOTED ON RADIOGRAPHIC IMAGING THAT THE LOCKING SCREWS DID NOT APPEAR TIGHT. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE LOCKING SCREWS AND EXTEND THE CONSTRUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9729765 ↗
• InjuryAug 8, 2018Loose or Intermittent Connection

  AT APPROXIMATELY SIX WEEKS POST-OPERATIVELY, LOOSE LOCKING SCREWS WERE NOTED ON ROUTINE RADIOGRAPHIC FOLLOW-UP WITHIN A MULTI-LEVEL CERVICO-THORACIC CONSTRUCT. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THESE LOCKING SCREWS AND THE RODS IN THE CONSTRUCT.

  Patient problems: No Code Available

  MAUDE report 7764921 ↗
• MalfunctionApr 6, 2018Detachment Of Device Component; Loose or Intermittent Connection

  AT APPROXIMATELY 4 MONTHS POST-OPERATIVELY, IT WAS NOTED ON ROUTINE FOLLOW-UP RADIOGRAPHS THAT THE ROD WAS DISSOCIATED FROM TWO SCREWS HEADS AT THE C2 AND C3 LEVELS ON ONE SIDE OF THE MULTI-LEVEL CERVICO-THORACIC CONSTRUCT WITH THE APPEARANCE OF LOOSE LOCKING SCREWS AT THOSE LEVELS . NO INTERVENTION HAS BEEN UNDERTAKEN. THE PATIENT REMAINS ASYMPTOMATIC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7404329 ↗
• MalfunctionApr 6, 2018Device Operates Differently Than Expected

  AT APPROXIMATELY SIX WEEKS POST-OPERATIVELY, IT WAS NOTED ON ROUTINE RADIOGRAPHIC FOLLOW-UP THAT A LOCKING SCREW WAS DISSOCIATED FROM THE SCREW HEAD AT THE T2 LEVEL ON ONE SIDE OF THE MULTI-LEVEL CERVICO-THORACIC CONSTRUCT. NO INTERVENTION HAS BEEN UNDERTAKEN. THE PATIENT REMAINS ASYMPTOMATIC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7404291 ↗
• InjuryDec 19, 2017Detachment Of Device Component

  AT APPROXIMATELY 6 WEEKS POST-OPERATIVELY, IT WAS NOTED ON RADIOGRAPHS THAT TWO LOCKING SCREWS WERE DETTACHED FROM THE SCREW HEADS AT THE C2 LEVEL. A SURGICAL PROCEDURE WAS PERFORMED AT WHICH TIME THE LOCKING SCREWS AT THE C2 LEVEL WERE REMOVED AND REPLACED. THE PATIENT IS RECOVERING SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7130989 ↗