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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device screw, fixation, bone
Product CodeHWC
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
A.M. SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACTIVORTHO, INC
  SUBSTANTIALLY EQUIVALENT 1
ACTIVORTHO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUMED LLC
  SUBSTANTIALLY EQUIVALENT 2
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 9
AUXANO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
AVANTI ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AZURMEDS INC.
  SUBSTANTIALLY EQUIVALENT 2
BESPA GLOBAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIEDERMANN MEDTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BRM EXTREMITIES
  SUBSTANTIALLY EQUIVALENT 1
BRM EXTREMITIES SRL
  SUBSTANTIALLY EQUIVALENT 1
CHM SP. Z O.O.
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTEMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CURVAFIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIAMOND ORTHOPEDIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
DOUBLE MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
EXSOMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
EXSOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXSOMED, CORP.
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 2
FIELD ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
FIELD ORTHOPAEDICS PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
FORMA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLW MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
GLW, INC.
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERCIO LTDA
  SUBSTANTIALLY EQUIVALENT 1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ICONN ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
INION OY
  SUBSTANTIALLY EQUIVALENT 1
INNOVATE ORTHOPAEDICS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MAXXION MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE INC
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 9
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 3
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCIRCLE SPINE D.B.A. OC MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSSIO LTD.
  SUBSTANTIALLY EQUIVALENT 3
OSTEOCENTRIC EXTREMITIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
OSTEOCENTRIC TRAUMA
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED LLC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28 INC.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 5
RELJA INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
RESPONSIVE ARTHROSCOPY LLC
  SUBSTANTIALLY EQUIVALENT 2
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
RETROFIX SCREWS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SAFETYFIX MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIGNUS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
STABILIZ ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 5
STUCKENBROCK MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SUBCHONDRAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC / DEPUY ORTHOPAEDICS INC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES USA PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TDM CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRAX SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
UNIVERSITY OF UTAH, DEPARTMENT OF ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
VILEX IN TENNESSEE, INC
  SUBSTANTIALLY EQUIVALENT 1
VILEX LLC
  SUBSTANTIALLY EQUIVALENT 1
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 1
VOOM MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2018 3658 3658
2019 5457 5461
2020 4816 4819
2021 4441 4504
2022 3933 4287
2023 3449 3449

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10776 11056
Break 5606 5680
Migration 1859 1918
Device-Device Incompatibility 1622 1622
Fracture 916 920
Material Twisted/Bent 492 492
No Apparent Adverse Event 446 446
Insufficient Information 399 399
Entrapment of Device 367 367
Device Slipped 361 361
Device Dislodged or Dislocated 296 307
Migration or Expulsion of Device 286 286
Appropriate Term/Code Not Available 278 278
Positioning Failure 219 219
Patient Device Interaction Problem 218 218
Detachment of Device or Device Component 215 215
Unintended Movement 213 213
Material Fragmentation 183 183
Material Separation 175 175
Material Deformation 175 175
Manufacturing, Packaging or Shipping Problem 170 170
Loosening of Implant Not Related to Bone-Ingrowth 152 152
Patient-Device Incompatibility 150 150
Difficult to Remove 139 139
Loss of Osseointegration 121 121
Loose or Intermittent Connection 113 113
Difficult to Advance 112 112
Crack 109 109
Corroded 96 96
Use of Device Problem 92 92
Material Integrity Problem 76 76
Mechanical Problem 71 71
Difficult to Insert 64 64
Malposition of Device 57 57
Device Operates Differently Than Expected 56 56
Failure to Advance 56 56
Failure to Align 49 49
Positioning Problem 47 47
Improper or Incorrect Procedure or Method 46 46
Osseointegration Problem 44 44
Mechanical Jam 42 42
Physical Resistance/Sticking 39 39
Material Split, Cut or Torn 36 36
Defective Device 33 33
Unstable 33 33
Packaging Problem 32 32
Bent 28 28
Detachment Of Device Component 27 27
Inadequacy of Device Shape and/or Size 27 27
Component Missing 27 27
Material Protrusion/Extrusion 24 24
Fitting Problem 24 24
Material Frayed 23 23
Device Markings/Labelling Problem 23 23
Naturally Worn 22 22
Loss of or Failure to Bond 22 22
Biocompatibility 21 21
Tear, Rip or Hole in Device Packaging 20 20
Compatibility Problem 20 20
Therapeutic or Diagnostic Output Failure 20 20
Failure to Cut 17 17
Material Discolored 17 17
Failure to Osseointegrate 16 16
Device Contaminated During Manufacture or Shipping 16 16
Off-Label Use 15 15
Material Erosion 15 15
Degraded 15 15
Noise, Audible 15 15
Dull, Blunt 14 14
Device Damaged Prior to Use 14 14
Contamination /Decontamination Problem 14 14
Incomplete or Missing Packaging 13 13
Device Damaged by Another Device 13 13
Device Difficult to Maintain 12 12
Activation, Positioning or Separation Problem 12 12
Failure To Adhere Or Bond 12 12
Flaked 11 11
Delivered as Unsterile Product 11 11
Separation Failure 11 11
Inaccurate Information 11 11
Device Handling Problem 9 9
Nonstandard Device 9 9
Peeled/Delaminated 8 8
Device Difficult to Setup or Prepare 8 8
Difficult or Delayed Positioning 8 8
Scratched Material 8 8
Expiration Date Error 7 7
Defective Component 7 7
Collapse 7 7
Material Disintegration 7 7
Unexpected Therapeutic Results 7 7
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Output Problem 6 6
Device Contamination with Chemical or Other Material 5 5
Mechanics Altered 5 5
Structural Problem 5 5
Deformation Due to Compressive Stress 5 5
Unraveled Material 5 5
Device Appears to Trigger Rejection 5 5
Separation Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 4825 4825
No Clinical Signs, Symptoms or Conditions 3558 3638
Pain 3094 3096
Non-union Bone Fracture 3046 3190
Unspecified Infection 2603 2603
Failure of Implant 1955 1971
No Consequences Or Impact To Patient 1357 1357
No Known Impact Or Consequence To Patient 1177 1184
Bone Fracture(s) 1105 1119
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 999 999
Insufficient Information 956 985
Injury 797 797
Foreign Body In Patient 770 776
Post Operative Wound Infection 518 518
Discomfort 489 489
No Information 475 475
Impaired Healing 444 444
Loss of Range of Motion 413 413
Necrosis 371 426
Hypersensitivity/Allergic reaction 365 365
Unspecified Tissue Injury 313 313
Not Applicable 253 253
Device Embedded In Tissue or Plaque 250 250
Nerve Damage 237 237
Reaction 193 193
Implant Pain 189 211
Malunion of Bone 179 202
Swelling 179 179
Skin Inflammation/ Irritation 174 174
No Patient Involvement 174 174
Wound Dehiscence 167 167
Physical Asymmetry 157 157
Swelling/ Edema 152 152
Inflammation 148 148
Arthritis 145 149
Tissue Damage 127 127
Inadequate Osseointegration 120 120
Irritation 112 112
Hematoma 112 112
Osteolysis 108 109
Numbness 82 82
Joint Dislocation 81 81
Ossification 80 80
Dysphagia/ Odynophagia 73 73
Muscle/Tendon Damage 73 73
Ambulation Difficulties 71 71
Foreign Body Reaction 67 67
Hip Fracture 67 67
Skin Irritation 62 62
Muscular Rigidity 61 61
Deformity/ Disfigurement 58 59
Patient Problem/Medical Problem 57 57
Scar Tissue 55 55
Rash 53 53
Paralysis 53 53
Bacterial Infection 53 53
Fall 51 51
Neurological Deficit/Dysfunction 49 49
Limited Mobility Of The Implanted Joint 43 43
Abscess 40 40
Limb Fracture 38 55
Unspecified Nervous System Problem 37 37
Spinal Column Injury 37 37
Rupture 37 37
Ulcer 36 40
Purulent Discharge 36 36
Erythema 36 36
Calcium Deposits/Calcification 35 35
Metal Related Pathology 35 35
Hypoesthesia 31 31
Adhesion(s) 30 30
Fatigue 28 28
Joint Laxity 28 28
Fistula 27 27
Synovitis 27 27
Weakness 26 26
Cyst(s) 26 26
Joint Disorder 26 26
Headache 25 25
Death 23 23
Hemorrhage/Bleeding 22 22
Difficulty Chewing 22 22
Thrombosis/Thrombus 21 21
Osteopenia/ Osteoporosis 21 21
Fluid Discharge 20 20
Emotional Changes 20 20
Cerebrospinal Fluid Leakage 20 20
Thrombosis 20 20
Erosion 19 19
Sleep Dysfunction 19 19
Seroma 18 18
Neuropathy 18 18
Perforation 17 17
Visual Impairment 17 17
Blood Loss 17 17
Inadequate Pain Relief 17 17
Fibrosis 16 16
Sepsis 16 16
Tingling 15 15
Pulmonary Embolism 15 15

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Dec-23-2022
2 Acumed LLC II Apr-20-2022
3 Arthrex, Inc. II Mar-17-2020
4 Biomet II Jun-09-2020
5 Biomet, Inc. II Dec-17-2020
6 Cayenne Medical Inc. II Jul-10-2018
7 CrossRoads Extremity Systems, LLC II Oct-24-2019
8 In2bones USA, LLC II Aug-21-2018
9 Integra Limited II Apr-05-2019
10 Medshape, INC. II Jan-04-2022
11 MicroPort Orthopedics Inc. II Oct-11-2018
12 Nextremity Solutions II Apr-12-2022
13 Nextremity Solutions II Mar-09-2022
14 Nextremity Solutions II Apr-27-2021
15 Nextremity Solutions II Feb-24-2020
16 Nextremity Solutions II Jan-03-2020
17 ORTHO SOLUTIONS, LTD. II Mar-09-2018
18 PROVIDENCE MEDICAL TECHNOLOGIES II Jun-25-2020
19 SCIENCE & BIO MATERIALS II Jul-08-2022
20 Smith & Nephew, Inc. II Oct-19-2021
21 Smith & Nephew, Inc. II Mar-20-2018
22 Stryker Corporation II Mar-02-2018
23 Synthes (USA) Products LLC II Oct-24-2018
24 Trilliant Surgical, LLC II Mar-30-2020
25 Wright Medical Technology, Inc. II Nov-25-2019
26 Zimmer Biomet, Inc. II Nov-07-2019
27 Zimmer Biomet, Inc. II May-09-2019
28 Zimmer Biomet, Inc. II Sep-14-2018
29 Zimmer Biomet, Inc. II May-08-2018
30 Zimmer Biomet, Inc. II Mar-15-2018
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