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Insignia 136-0121Recalls & reported problems

Alphatec Spine, Inc. · Insignia, ACP, 1-Level, 21 mm · Class 2 · Implant

All models of Insignia (34)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190376268477), received between Apr 21, 2021 and Apr 21, 2021 — classified as 1 malfunction.

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

Most reported problems

Device problems

  • Break1

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.

  • MalfunctionApr 21, 2021Break

    LOCKING MECHANISM OF PLATE BROKE OFF WHEN SURGEON WAS LOCKING DOWN WITH DRIVER. THE DAMAGED PLATE WAS REMOVED FROM PATIENT AND ANOTHER PLATE INSTALLED. THERE WAS NO DELAY IN SURGICAL PROCEDURE.

    Patient problems: Insufficient Information

    MAUDE report 11700760 ↗

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-1810-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01)00190376268392
  • Z-1801-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446
  • Z-1822-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620
  • Z-1809-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
  • 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-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-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-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-1815-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268538
  • Z-1799-2021 · Apr 26, 2021 · Terminated
    Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422
  • 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-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-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

…and 14 more.

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Sources and updates

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