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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthosis, spinal pedicle fixation
Product CodeMNI
Regulation Number 888.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
A-SPINE ASIA, CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ACCEL SPINE
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
ALTUS PARTNERS
  SUBSTANTIALLY EQUIVALENT 1
BEIJING WEIGAO YAHUA ARTIFICIAL JOINT DEVELOPMENT CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOTECHNI AMERICA SPINE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAPTIVA SPINE
  SUBSTANTIALLY EQUIVALENT 1
CAPTIVA SPINE, INC
  SUBSTANTIALLY EQUIVALENT 2
CG BIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
CORE-NEXUS
  SUBSTANTIALLY EQUIVALENT 1
CORELINK LLC
  SUBSTANTIALLY EQUIVALENT 1
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
DEPUY SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIO MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DOUBLE MEDICAL TECHNOLOGY INC
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE SURGICAL DESIGNS
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 11
K7 LLC
  SUBSTANTIALLY EQUIVALENT 1
KISCO INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
KOREA BONE BANK CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
L & K BIOMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
LANX, LLC
  SUBSTANTIALLY EQUIVALENT 1
LDR SPINE USA
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 3
MEDICREA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
MEDYSSEY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
MIGHTY OAK MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
MIKRON MAKINA SANAYI TICARET CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIKRON MAKINA SANAYI VE TICARET LTD STI
  SUBSTANTIALLY EQUIVALENT 1
NEW ERA ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEW ERA ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 2
OSTEOMED IMPLANTES, LTDA
  SUBSTANTIALLY EQUIVALENT 1
PHYGEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 4
RENOVIS SURGICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROBERT REID INC.
  SUBSTANTIALLY EQUIVALENT 1
SAVANNAH TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SINTEA PLASTEK, LLC
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL USA
  SUBSTANTIALLY EQUIVALENT 6
SPINE ART
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 8
SPINE360
  SUBSTANTIALLY EQUIVALENT 1
SPINEART
  SUBSTANTIALLY EQUIVALENT 4
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION S.A.
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION, S.A.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES SPINE
  SUBSTANTIALLY EQUIVALENT 1
THEKEN SPINE LLC
  SUBSTANTIALLY EQUIVALENT 2
TIANJIN WALKMAN BIOMATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 301 301
2015 260 260
2016 117 117
2017 246 246
2018 134 134
2019 188 188
2020 115 115
2021 274 274
2022 215 215
2023 123 123
2024 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 565 565
Break 525 525
Fracture 146 146
Loose or Intermittent Connection 92 92
Migration or Expulsion of Device 85 85
Device Slipped 78 78
Device Dislodged or Dislocated 66 66
Material Integrity Problem 64 64
Device-Device Incompatibility 54 54
Mechanical Problem 53 53
Insufficient Information 52 52
No Apparent Adverse Event 51 51
Migration 50 50
Material Separation 48 48
Appropriate Term/Code Not Available 47 47
Device Operates Differently Than Expected 45 45
Detachment of Device or Device Component 44 44
Material Deformation 40 40
Detachment Of Device Component 37 37
Unintended Movement 31 31
Patient Device Interaction Problem 29 29
Material Fragmentation 23 23
Malposition of Device 23 23
Entrapment of Device 21 21
Failure To Adhere Or Bond 20 20
Material Twisted/Bent 19 19
Compatibility Problem 17 17
Fitting Problem 16 16
Disassembly 16 16
Torn Material 14 14
Loosening of Implant Not Related to Bone-Ingrowth 12 12
Defective Device 11 11
Connection Problem 10 10
Difficult to Remove 10 10
Noise, Audible 10 10
Mechanical Jam 10 10
Positioning Problem 9 9
Improper or Incorrect Procedure or Method 9 9
Bent 9 9
Device Operational Issue 9 9
Use of Device Problem 8 8
Crack 7 7
Difficult to Advance 7 7
Difficult to Insert 6 6
Difficult To Position 6 6
Material Split, Cut or Torn 6 6
Disconnection 5 5
Device Damaged by Another Device 5 5
Patient-Device Incompatibility 5 5
Failure to Advance 5 5
Structural Problem 4 4
Failure to Align 4 4
Defective Component 4 4
Separation Failure 4 4
Sticking 4 4
Inadequacy of Device Shape and/or Size 3 3
Peeled/Delaminated 3 3
Component Falling 3 3
Component or Accessory Incompatibility 3 3
Naturally Worn 3 3
Packaging Problem 2 2
Physical Resistance/Sticking 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Torqued 2 2
Tear, Rip or Hole in Device Packaging 2 2
Component Missing 2 2
Device Damaged Prior to Use 2 2
Split 2 2
Loss of or Failure to Bond 2 2
Material Disintegration 2 2
Nonstandard Device 2 2
Product Quality Problem 2 2
Metal Shedding Debris 2 2
Failure to Osseointegrate 1 1
Stretched 1 1
Inadequate or Insufficient Training 1 1
Unstable 1 1
Unintended Collision 1 1
Misassembled 1 1
Degraded 1 1
Corroded 1 1
Solder Joint Fracture 1 1
Device Displays Incorrect Message 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Contamination /Decontamination Problem 1 1
Material Protrusion/Extrusion 1 1
Human Factors Issue 1 1
Device Markings/Labelling Problem 1 1
Physical Property Issue 1 1
Output Problem 1 1
Mechanics Altered 1 1
Measurement System Incompatibility 1 1
Misassembly by Users 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 387 387
No Code Available 295 295
Failure of Implant 219 219
Pain 215 215
No Clinical Signs, Symptoms or Conditions 179 179
No Information 124 124
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 112 112
Injury 102 102
Non-union Bone Fracture 92 92
Insufficient Information 87 87
Post Operative Wound Infection 83 83
Nerve Damage 78 78
No Consequences Or Impact To Patient 75 75
Unspecified Infection 61 61
Impaired Healing 53 53
Unspecified Tissue Injury 50 50
Bone Fracture(s) 49 49
Osteolysis 48 48
Hematoma 35 35
Device Embedded In Tissue or Plaque 33 33
Foreign Body In Patient 32 32
Joint Laxity 28 28
Perforation of Vessels 28 28
Cerebrospinal Fluid Leakage 25 25
Intervertebral Disc Compression or Protrusion 24 24
Physical Asymmetry 20 20
Discomfort 20 20
Decreased Sensitivity 17 17
Not Applicable 16 16
Vertebral Fracture 16 16
Spinal Column Injury 16 16
Fall 15 15
Spinal Cord Injury 13 13
Joint Disorder 12 12
Limited Mobility Of The Implanted Joint 12 12
Stenosis 12 12
Neck Pain 11 11
Ambulation Difficulties 10 10
Neuralgia 10 10
Neurological Deficit/Dysfunction 10 10
Malunion of Bone 9 9
Sudden Cardiac Death 8 8
Patient Problem/Medical Problem 8 8
Sedation 8 8
Death 7 7
Necrosis 7 7
Loss of Range of Motion 6 6
Complaint, Ill-Defined 6 6
Weakness 5 5
Thrombosis 5 5
Hemorrhage/Bleeding 5 5
Implant Pain 5 5
Numbness 4 4
Nervous System Injury 4 4
No Patient Involvement 4 4
Thromboembolism 4 4
Unspecified Nervous System Problem 4 4
Therapeutic Effects, Unexpected 4 4
Rash 3 3
Seroma 3 3
Perforation 3 3
Fatigue 3 3
Wound Dehiscence 3 3
Pulmonary Embolism 3 3
Irritation 3 3
Incontinence 3 3
Hypersensitivity/Allergic reaction 3 3
Thrombosis/Thrombus 3 3
Unspecified Kidney or Urinary Problem 2 2
Inadequate Pain Relief 2 2
Paralysis 2 2
Undesired Nerve Stimulation 2 2
Muscular Rigidity 2 2
Myocardial Infarction 2 2
Nausea 2 2
Ossification 2 2
Arthritis 2 2
Headache 2 2
Respiratory Distress 2 2
Synovitis 2 2
Tissue Damage 2 2
Urinary Tract Infection 1 1
Visual Impairment 1 1
Swelling 1 1
Scarring 1 1
Sepsis 1 1
Pneumothorax 1 1
Positive antinuclear antibodies (ANA) 1 1
Chills 1 1
Hypoesthesia 1 1
Hypoesthesia, Foot/Leg 1 1
Deformity/ Disfigurement 1 1
Urinary Frequency 1 1
Pressure Sores 1 1
Anxiety 1 1
Heart Failure 1 1
Rupture 1 1
Brain Injury 1 1
Excessive Tear Production 1 1
Peritonitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Blackstone Medical, Inc. II Mar-16-2010
2 Blackstone Medical, Inc. II Jul-06-2009
3 CTL Medical Corporation II Mar-20-2019
4 Captiva Spine, Inc II Nov-21-2012
5 EBI, L.P. III Sep-22-2009
6 Exactech, Inc. II Mar-18-2014
7 Medicrea International II Aug-24-2023
8 New Era Orthopaedics, LLc II Aug-03-2018
9 Orthopedic Alliance LLC II Apr-22-2013
10 Spinal Solutions, LLC II May-27-2013
11 SpineFrontier, Inc. II Dec-20-2013
12 SpineFrontier, Inc. II Dec-19-2013
13 SpineFrontier, Inc. II Jul-16-2013
14 Stryker Spine II Aug-22-2012
15 Stryker Spine II Apr-10-2009
16 Synthes (USA) Products LLC II Oct-17-2015
17 Synthes (USA) Products LLC II Jul-20-2012
18 Synthes USA HQ, Inc. II Aug-09-2013
19 Valorem Surgical LLC II Aug-10-2017
20 Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK II Mar-12-2009
21 Zimmer Inc. II Aug-31-2010
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