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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 8
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
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
CURVAFIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
FORMA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
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
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INION OY
  SUBSTANTIALLY EQUIVALENT 1
INNOVATE ORTHOPAEDICS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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 3
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 8
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 4
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCIRCLE SPINE D.B.A. OC MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSSIO LTD.
  SUBSTANTIALLY EQUIVALENT 4
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 4
RELJA INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
RESPONSIVE ARTHROSCOPY LLC
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
RETROFIX SCREWS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIGNUS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW INC.
  SUBSTANTIALLY EQUIVALENT 1
STABILIZ ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 4
SUBCHONDRAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC / DEPUY ORTHOPAEDICS INC
  SUBSTANTIALLY EQUIVALENT 1
TDM CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRAX SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
TRIMED, INC
  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 4
ZIMED MEDIKAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5457 5461
2020 4816 4819
2021 4441 4504
2022 3933 4287
2023 3737 3737
2024 1437 1437

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10221 10501
Break 5050 5124
Migration 1945 2004
Device-Device Incompatibility 1643 1643
Fracture 798 802
Material Twisted/Bent 474 474
No Apparent Adverse Event 447 447
Entrapment of Device 408 408
Device Slipped 359 359
Insufficient Information 295 295
Device Dislodged or Dislocated 271 282
Patient Device Interaction Problem 225 225
Appropriate Term/Code Not Available 222 222
Positioning Failure 213 213
Detachment of Device or Device Component 199 199
Migration or Expulsion of Device 198 198
Material Deformation 181 181
Manufacturing, Packaging or Shipping Problem 177 177
Material Separation 173 173
Loosening of Implant Not Related to Bone-Ingrowth 170 170
Material Fragmentation 166 166
Unintended Movement 155 155
Difficult to Advance 126 126
Patient-Device Incompatibility 123 123
Difficult to Remove 110 110
Loss of Osseointegration 105 105
Use of Device Problem 94 94
Material Integrity Problem 80 80
Crack 78 78
Loose or Intermittent Connection 67 67
Difficult to Insert 54 54
Failure to Advance 54 54
Corroded 52 52
Mechanical Problem 49 49
Osseointegration Problem 45 45
Defective Device 44 44
Improper or Incorrect Procedure or Method 42 42
Mechanical Jam 41 41
Positioning Problem 37 37
Physical Resistance/Sticking 37 37
Malposition of Device 37 37
Unstable 31 31
Material Split, Cut or Torn 29 29
Failure to Align 26 26
Tear, Rip or Hole in Device Packaging 26 26
Device Contaminated During Manufacture or Shipping 25 25
Fitting Problem 24 24
Inadequacy of Device Shape and/or Size 23 23
Compatibility Problem 23 23
Therapeutic or Diagnostic Output Failure 20 20
Packaging Problem 19 19
Off-Label Use 19 19
Contamination /Decontamination Problem 18 18
Component Missing 17 17
Device Damaged Prior to Use 16 16
Failure to Cut 15 15
Naturally Worn 15 15
Material Protrusion/Extrusion 14 14
Device Damaged by Another Device 13 13
Loss of or Failure to Bond 13 13
Degraded 12 12
Failure to Osseointegrate 12 12
Device Markings/Labelling Problem 12 12
Device Difficult to Maintain 12 12
Inaccurate Information 12 12
Noise, Audible 12 12
Device Handling Problem 11 11
Delivered as Unsterile Product 11 11
Activation, Positioning or Separation Problem 10 10
Scratched Material 9 9
Biocompatibility 8 8
Difficult or Delayed Positioning 8 8
Nonstandard Device 8 8
Device Difficult to Setup or Prepare 8 8
Unexpected Therapeutic Results 7 7
Incomplete or Missing Packaging 7 7
Expiration Date Error 7 7
Separation Failure 6 6
Output Problem 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Material Erosion 6 6
Material Disintegration 5 5
Material Frayed 5 5
Product Quality Problem 5 5
Device Appears to Trigger Rejection 5 5
Unraveled Material 5 5
Defective Component 5 5
Firing Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Difficult to Open or Remove Packaging Material 4 4
Structural Problem 4 4
Collapse 4 4
Labelling, Instructions for Use or Training Problem 4 4
Peeled/Delaminated 4 4
Unsealed Device Packaging 3 3
Connection Problem 3 3
Separation Problem 3 3
Failure to Clean Adequately 3 3
Misassembled During Installation 2 2
Wrong Label 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4046 4126
No Code Available 4010 4010
Non-union Bone Fracture 2970 3114
Pain 2821 2823
Unspecified Infection 2257 2257
Failure of Implant 1838 1854
Insufficient Information 1390 1419
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1002 1002
Bone Fracture(s) 992 1006
No Consequences Or Impact To Patient 883 883
Foreign Body In Patient 797 803
Injury 735 735
No Known Impact Or Consequence To Patient 697 704
Post Operative Wound Infection 526 526
Discomfort 451 451
Loss of Range of Motion 411 411
Necrosis 393 448
Impaired Healing 357 357
Hypersensitivity/Allergic reaction 333 333
Unspecified Tissue Injury 327 327
No Information 278 278
Nerve Damage 244 244
Implant Pain 224 246
Malunion of Bone 211 234
Device Embedded In Tissue or Plaque 200 200
Physical Asymmetry 188 188
Skin Inflammation/ Irritation 180 180
Wound Dehiscence 164 164
Swelling/ Edema 163 163
Arthritis 147 151
Reaction 139 139
No Patient Involvement 135 135
Not Applicable 126 126
Inflammation 123 123
Hematoma 118 118
Swelling 102 102
Tissue Damage 102 102
Inadequate Osseointegration 100 100
Osteolysis 100 101
Numbness 92 92
Deformity/ Disfigurement 92 93
Muscular Rigidity 84 84
Muscle/Tendon Damage 80 80
Irritation 74 74
Joint Dislocation 72 72
Scar Tissue 69 69
Ossification 68 68
Foreign Body Reaction 67 67
Ambulation Difficulties 65 65
Fall 60 60
Adhesion(s) 59 59
Hip Fracture 59 59
Dysphagia/ Odynophagia 58 58
Neurological Deficit/Dysfunction 49 49
Paralysis 47 47
Skin Irritation 46 46
Limb Fracture 45 62
Rash 44 44
Bacterial Infection 42 42
Abscess 42 42
Unspecified Nervous System Problem 37 37
Patient Problem/Medical Problem 36 36
Ulcer 36 40
Metal Related Pathology 35 35
Purulent Discharge 34 34
Rupture 33 33
Calcium Deposits/Calcification 32 32
Synovitis 31 31
Joint Laxity 29 29
Fistula 28 28
Fatigue 27 27
Limited Mobility Of The Implanted Joint 27 27
Hypoesthesia 26 26
Joint Disorder 26 26
Cyst(s) 24 24
Hemorrhage/Bleeding 23 23
Weakness 22 22
Neuropathy 22 22
Osteopenia/ Osteoporosis 22 22
Thrombosis/Thrombus 22 22
Sepsis 21 21
Thrombosis 20 20
Emotional Changes 20 20
Cerebrospinal Fluid Leakage 19 19
Fluid Discharge 19 19
Headache 18 18
Seroma 18 18
Visual Impairment 17 17
Inadequate Pain Relief 17 17
Joint Contracture 17 17
Perforation 16 16
Local Reaction 16 16
Death 16 16
Pulmonary Embolism 15 15
Erythema 15 15
Fibrosis 15 15
Sleep Dysfunction 15 15
Increased Sensitivity 14 14
Intervertebral Disc Compression or Protrusion 13 13
Blood Loss 13 13

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 CrossRoads Extremity Systems, LLC II Oct-24-2019
7 In2Bones, SAS II Mar-20-2024
8 Integra Limited II Apr-05-2019
9 Medshape, INC. II Jan-04-2022
10 Nextremity Solutions II Apr-12-2022
11 Nextremity Solutions II Mar-09-2022
12 Nextremity Solutions II Apr-27-2021
13 Nextremity Solutions II Feb-24-2020
14 Nextremity Solutions II Jan-03-2020
15 PROVIDENCE MEDICAL TECHNOLOGIES II Jun-25-2020
16 SCIENCE & BIO MATERIALS II Jul-08-2022
17 Smith & Nephew, Inc. II Oct-19-2021
18 Trilliant Surgical, LLC II Mar-30-2020
19 Wright Medical Technology, Inc. II Nov-25-2019
20 Zimmer Biomet, Inc. II Nov-07-2019
21 Zimmer Biomet, Inc. II May-09-2019
22 Zimmer, Inc. II Apr-30-2024
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