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Insignia 136-0358Recalls & reported problems

Alphatec Spine, Inc. · Insignia, ACP, 3 Level, 58 mm · Class 2 · Implant

All models of Insignia (34)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190376268606), received between May 17, 2021 and May 17, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

29 other recalls cover devices cleared under the same FDA submission (K200995); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 17, 2021Detachment of Device or Device Component

    POST OPERATIVELY, IT WAS NOTICED IN X-RAYS THAT THE LOCKING MECHANISM FOR THE PLATE HAS POPPED OFF. THERE HAS NOT BEEN ANY REVISION SURGERY SCHEDULED AT THIS TIME. SCREWS HAVE NOT BACKED OUT.

    Patient problems: Insufficient Information

    MAUDE report 11838534 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200995. One submission often covers many models, so check the product and lot details in each record.

  • Z-1816-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569
  • Z-1807-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm, Rx Only, Non-Sterile, UDI: (01)00190376268361
  • Z-1820-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606
  • Z-1802-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453
  • Z-1800-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439
  • Z-1812-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415
  • Z-1826-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705
  • Z-1814-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
  • Z-1813-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
  • Z-1818-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583
  • Z-1819-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590
  • Z-1805-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
  • Z-1824-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675
  • Z-1803-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
  • Z-1811-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408

…and 14 more.

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Sources and updates

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