Insignia 136-2-14016Recalls & reported problems

Alphatec Spine, Inc. · 4.0mm Variable Angle, Self Tapping Screw, Dual Lead 16mm · 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 00190376266183), received between Mar 5, 2021 and Mar 5, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

Device Dislodged or Dislocated1
Material Protrusion/Extrusion1

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.

MalfunctionMar 5, 2021Device Dislodged or Dislocated; Material Protrusion/Extrusion
POST OP IMAGES REVEALED THE TWO SCREW HAVE BACKED OUT AND ARE PROTRUDING JUST PAST THE LOCKING MECHANISM. NO REVISION SURGERY SCHEDULED AT THIS TIME. THE INSIGNIA ANTERIOR CERVICAL PLATE SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2021.
Patient problems: Insufficient Information
MAUDE report 11424235 ↗

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-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-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-1806-2021 · Apr 26, 2021 · Terminated
Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
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-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-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-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-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-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-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-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

…and 14 more.

Device details

UDI-DI	`00190376266183`
Brand	Insignia
Model	136-2-14016
Company	Alphatec Spine, Inc.
Product code	KWQ · Appliance, fixation, spinal intervertebral body
Class	Class 2
FDA submission	K200995
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 11, 2024

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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All Appliance, fixation, spinal intervertebral body devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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