Insignia 136-2-24014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190376241869), received between May 20, 2021 and May 20, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Slipped” (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

Recent adverse event reports

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

• InjuryMay 20, 2021Device Slipped

  SCREWS AT THE TOP LEVEL PULLED OUT POST-OP.

  Patient problems: Insufficient Information

  MAUDE report 11861174 ↗

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-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-1827-2021 · Apr 26, 2021 · Terminated
  Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712
• 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-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-1823-2021 · Apr 26, 2021 · Terminated
  Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
• 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-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-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-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-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-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
• 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-1817-2021 · Apr 26, 2021 · Terminated
  Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
• 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-1821-2021 · Apr 26, 2021 · Terminated
  Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613

…and 14 more.