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Invictus 17806Recalls & reported problems

Alphatec Spine, Inc. · Final Driver, Universal Cross Connector · Class 1

Adverse event reports
13
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00190376331683), received between Aug 6, 2025 and Sep 24, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Break” (13 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 4 reportsMay 2026: 5 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break13
  • Material Separation12

Patient problems

  • No Clinical Signs, Symptoms or Conditions12
  • Foreign Body In Patient1

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 24, 2026Break; Material Separation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50890246 ↗
  • MalfunctionMay 13, 2026Break; Material Separation

    IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHEN FINAL TIGHTENING A CROSS LINK. THE TIP WAS RETRIEVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25164906 ↗
  • MalfunctionMay 13, 2026Break; Material Separation

    IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHEN REMOVING A CROSSLINK. THE TIP WAS RETRIEVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25163908 ↗
  • MalfunctionMay 13, 2026Break; Material Separation

    IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHEN REMOVING A CROSSLINK. THE TIP WAS RETRIEVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25163773 ↗
  • MalfunctionMay 6, 2026Break; Material Separation

    IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF REMOVING A CROSS-LINK TO EXTEND FUSION. THE TIP WAS RETRIEVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25101369 ↗
  • MalfunctionMay 5, 2026Break

    THE TIP OF THE SCREWDRIVER BROKE OFF. IT WAS RETRIEVED FROM THE PATIENT AND THE INSTRUMENT WAS DISCARDED AT THE HOSPITAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25086618 ↗
  • MalfunctionApr 29, 2026Break; Material Separation

    IT WAS REPORTED THAT THE DRIVER IS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25034439 ↗
  • MalfunctionApr 29, 2026Break; Material Separation

    IT WAS REPORTED THAT THE TIP OF THE DRIVER IS STRIPPED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25034211 ↗
  • MalfunctionApr 29, 2026Break; Material Separation

    IT WAS REPORTED THAT THE TIP OF THE DRIVER IS STRIPPED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25033907 ↗
  • MalfunctionApr 2, 2026Break; Material Separation

    IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE WHILE REMOVING A CROSS CONNECTOR. THE TIP WAS RETRIEVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24768868 ↗
  • MalfunctionOct 16, 2025Break; Material Separation; Break; Material Separation

    IT WAS REPORTED THAT THE DRIVER BROKE DURING A CASE. THE TIP WAS RETRIEVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23311376 ↗
  • MalfunctionSep 17, 2025Break; Material Separation; Break; Material Separation

    IT WAS REPORTED THAT THE DRIVER IS WORN AND NOT FUNCTIONING AS EXPECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23074688 ↗
  • InjuryAug 6, 2025Break; Material Separation; Break; Material Separation

    IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THE TIP WAS UNABLE TO BE REMOVED AND REMAINS IN THE PATIENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 22731721 ↗

Other SCREWDRIVER devices

All SCREWDRIVER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.