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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 5
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 1
DOUBLE MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 3
EXSOMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
EXSOMED, CORP.
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 2
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 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 2
MEDSHAPE INC
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 4
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
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
PARAGON 28 INC.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 1
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 LLC
  SUBSTANTIALLY EQUIVALENT 2
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 1
ZIMED MEDIKAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 4816 4819
2021 4441 4504
2022 3935 4289
2023 3737 3737
2024 3597 3597
2025 466 466

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8857 9137
Break 4772 4842
Migration 1815 1874
Device-Device Incompatibility 1666 1666
Fracture 687 691
Entrapment of Device 457 457
Material Twisted/Bent 444 444
Device Slipped 289 289
Positioning Failure 239 239
No Apparent Adverse Event 237 237
Device Dislodged or Dislocated 217 228
Patient Device Interaction Problem 213 213
Insufficient Information 198 198
Loosening of Implant Not Related to Bone-Ingrowth 191 191
Material Deformation 188 188
Manufacturing, Packaging or Shipping Problem 169 169
Material Fragmentation 161 161
Detachment of Device or Device Component 136 136
Patient-Device Incompatibility 135 135
Migration or Expulsion of Device 134 134
Difficult to Advance 134 134
Appropriate Term/Code Not Available 117 117
Unintended Movement 91 91
Difficult to Remove 86 86
Material Integrity Problem 86 86
Use of Device Problem 85 85
Material Separation 82 82
Crack 77 77
Loss of Osseointegration 67 67
Mechanical Jam 53 53
Improper or Incorrect Procedure or Method 41 41
Defective Device 39 39
Physical Resistance/Sticking 37 37
Difficult to Insert 37 37
Failure to Advance 35 35
Mechanical Problem 35 35
Device Contaminated During Manufacture or Shipping 28 28
Tear, Rip or Hole in Device Packaging 24 24
Compatibility Problem 24 24
Material Split, Cut or Torn 24 24
Off-Label Use 24 24
Unstable 22 22
Biocompatibility 21 21
Malposition of Device 21 21
Inadequacy of Device Shape and/or Size 20 20
Fitting Problem 20 20
Loose or Intermittent Connection 19 19
Positioning Problem 18 18
Osseointegration Problem 18 18
Corroded 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4852 4932
Non-union Bone Fracture 2795 2939
Pain 2175 2177
Insufficient Information 1906 1935
Failure of Implant 1753 1769
No Code Available 1741 1741
Unspecified Infection 1607 1607
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1002 1002
Foreign Body In Patient 825 827
Bone Fracture(s) 726 740
Injury 537 537
Post Operative Wound Infection 528 528
No Consequences Or Impact To Patient 464 464
Unspecified Tissue Injury 368 368
Discomfort 334 334
Loss of Range of Motion 327 327
Hypersensitivity/Allergic reaction 293 293
Implant Pain 284 306
Skin Inflammation/ Irritation 270 270
No Known Impact Or Consequence To Patient 261 264
Malunion of Bone 257 280
Physical Asymmetry 253 253
Necrosis 252 307
Impaired Healing 224 224
Swelling/ Edema 187 187
Nerve Damage 185 185
Wound Dehiscence 158 158
Device Embedded In Tissue or Plaque 120 120
Muscular Rigidity 120 120
No Information 117 117
Inflammation 105 105
Arthritis 105 109
Deformity/ Disfigurement 104 105
Hematoma 94 94
Numbness 82 82
Muscle/Tendon Damage 81 81
Foreign Body Reaction 78 78
Ambulation Difficulties 77 77
Reaction 74 74
Osteolysis 71 72
Distress 71 71
Inadequate Osseointegration 64 64
Joint Dislocation 62 62
Fall 59 59
Adhesion(s) 56 56
Hip Fracture 54 54
Abscess 54 54
No Patient Involvement 51 51
Rash 49 49
Limb Fracture 47 64

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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