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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
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeHWC
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
AAP IMPLANTATE AG
  SUBSTANTIALLY EQUIVALENT 1
ACUMED, LLC
  SUBSTANTIALLY EQUIVALENT 2
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 7
ASTRA ORTHOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
BRM EXTREMITIES
  SUBSTANTIALLY EQUIVALENT 1
BRM EXTREMITIES SRL
  SUBSTANTIALLY EQUIVALENT 1
CHM SP. Z O.O.
  SUBSTANTIALLY EQUIVALENT 1
CURVAFIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEV4
  SUBSTANTIALLY EQUIVALENT 2
DOUBLE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
DUNAMIS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXSOMED CORP.
  SUBSTANTIALLY EQUIVALENT 2
EXTREMITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 3
FIELD ORTHOPAEDICS PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
FLOWER ORTHOPEDICS CORPORATION DBA CONVENTUS FLOWER ORTHO
  SUBSTANTIALLY EQUIVALENT 1
FORMA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
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
INNOVATE ORTHOPAEDICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MAXXION MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S .A.
  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 2
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 6
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCIRCLE SPINE D.B.A. OC MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHONOVIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSSIO, LTD.
  SUBSTANTIALLY EQUIVALENT 5
OSTEOCENTRIC EXTREMITIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 4
OSTEOMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
PACE SURGICAL
  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 3
SUBCHONDRAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TIGON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TRAX SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 4
TYBER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
UNIVERSITY OF UTAH, DEPARTMENT OF ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 3
VOOM MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
WRIGHTMEDICALTECHNOLOGYINC
  SUBSTANTIALLY EQUIVALENT 1
ZIMED MEDIKAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 4820 4836
2021 4446 4519
2022 3934 4331
2023 3718 3738
2024 3575 3582
2025 2702 2784

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9473 9854
Break 5408 5494
Migration 1985 2050
Device-Device Incompatibility 1874 1879
Fracture 779 790
Material Twisted/Bent 529 529
Entrapment of Device 516 517
Device Slipped 302 303
No Apparent Adverse Event 280 280
Positioning Failure 274 274
Device Dislodged or Dislocated 252 266
Patient Device Interaction Problem 251 251
Material Deformation 239 240
Loosening of Implant Not Related to Bone-Ingrowth 227 231
Insufficient Information 207 207
Manufacturing, Packaging or Shipping Problem 204 204
Material Fragmentation 197 197
Detachment of Device or Device Component 163 166
Difficult to Advance 150 150
Patient-Device Incompatibility 146 150
Migration or Expulsion of Device 136 136
Appropriate Term/Code Not Available 127 127
Use of Device Problem 104 104
Unintended Movement 96 96
Material Integrity Problem 91 92
Difficult to Remove 89 89
Crack 87 87
Material Separation 83 83
Loss of Osseointegration 67 67
Mechanical Jam 57 58
Off-Label Use 48 48
Defective Device 45 47
Mechanical Problem 45 46
Difficult to Insert 43 43
Physical Resistance/Sticking 43 43
Failure to Advance 42 42
Improper or Incorrect Procedure or Method 41 41
Biocompatibility 38 38
Device Contaminated During Manufacture or Shipping 38 38
Osseointegration Problem 30 30
Material Split, Cut or Torn 27 27
Loose or Intermittent Connection 26 26
Tear, Rip or Hole in Device Packaging 25 25
Inadequacy of Device Shape and/or Size 23 29
Unstable 22 22
Malposition of Device 22 22
Compatibility Problem 22 22
Positioning Problem 22 22
Fitting Problem 20 20
Corroded 20 37

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5735 5824
Non-union Bone Fracture 3098 3256
Pain 2376 2416
Insufficient Information 2242 2317
Failure of Implant 1809 1852
No Code Available 1741 1741
Unspecified Infection 1711 1725
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1014 1014
Foreign Body In Patient 942 947
Bone Fracture(s) 800 814
Injury 537 537
Post Operative Wound Infection 536 538
No Consequences Or Impact To Patient 464 464
Unspecified Tissue Injury 384 384
Hypersensitivity/Allergic reaction 368 369
Loss of Range of Motion 352 360
Discomfort 349 356
Implant Pain 304 332
Malunion of Bone 304 333
Skin Inflammation/ Irritation 283 283
Physical Asymmetry 265 265
Necrosis 264 320
No Known Impact Or Consequence To Patient 261 264
Impaired Healing 254 259
Swelling/ Edema 200 203
Nerve Damage 190 192
Wound Dehiscence 170 170
Device Embedded In Tissue or Plaque 142 148
Muscular Rigidity 128 133
No Information 117 117
Arthritis 112 119
Inflammation 111 112
Deformity/ Disfigurement 108 109
Hematoma 96 96
Foreign Body Reaction 90 92
Numbness 86 90
Muscle/Tendon Damage 83 84
Ambulation Difficulties 82 82
Osteolysis 76 77
Reaction 75 77
Fall 71 71
Distress 71 71
Inadequate Osseointegration 69 69
Joint Dislocation 64 66
Adhesion(s) 58 63
Hip Fracture 54 54
Limb Fracture 51 68
No Patient Involvement 51 51
Abscess 50 51
Rash 49 50

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 In2Bones, SAS II Mar-20-2024
7 Medartis Inc. II May-14-2024
8 Medshape, INC. II Jan-04-2022
9 Nextremity Solutions II Apr-12-2022
10 Nextremity Solutions II Mar-09-2022
11 Nextremity Solutions II Apr-27-2021
12 Nextremity Solutions II Feb-24-2020
13 Nextremity Solutions II Jan-03-2020
14 PROVIDENCE MEDICAL TECHNOLOGIES II Jun-25-2020
15 SCIENCE & BIO MATERIALS II Jul-08-2022
16 Smith & Nephew, Inc. II Oct-19-2021
17 TriMed Inc. II May-10-2024
18 Trilliant Surgical, LLC II Mar-30-2020
19 Zimmer, Inc. II Apr-30-2024
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