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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
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 1
EXSOMED, CORP.
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC
  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 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
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
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 3
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 4820 4836
2021 4446 4515
2022 3934 4304
2023 3718 3718
2024 3575 3575
2025 2373 2459

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9318 9679
Break 5355 5429
Migration 1974 2033
Device-Device Incompatibility 1850 1852
Fracture 767 771
Entrapment of Device 510 510
Material Twisted/Bent 498 498
Device Slipped 302 302
No Apparent Adverse Event 270 270
Positioning Failure 268 268
Device Dislodged or Dislocated 246 259
Patient Device Interaction Problem 245 245
Material Deformation 231 231
Loosening of Implant Not Related to Bone-Ingrowth 215 218
Insufficient Information 206 206
Manufacturing, Packaging or Shipping Problem 203 203
Material Fragmentation 197 197
Detachment of Device or Device Component 161 164
Difficult to Advance 150 150
Patient-Device Incompatibility 146 150
Migration or Expulsion of Device 135 135
Appropriate Term/Code Not Available 127 127
Use of Device Problem 103 103
Unintended Movement 95 95
Material Integrity Problem 90 90
Difficult to Remove 89 89
Crack 87 87
Material Separation 83 83
Loss of Osseointegration 67 67
Mechanical Jam 57 57
Off-Label Use 48 48
Defective Device 45 45
Mechanical Problem 45 46
Physical Resistance/Sticking 43 43
Difficult to Insert 43 43
Improper or Incorrect Procedure or Method 41 41
Failure to Advance 41 41
Biocompatibility 38 38
Device Contaminated During Manufacture or Shipping 37 37
Osseointegration Problem 30 30
Material Split, Cut or Torn 27 27
Loose or Intermittent Connection 25 25
Tear, Rip or Hole in Device Packaging 25 25
Inadequacy of Device Shape and/or Size 23 29
Malposition of Device 22 22
Positioning Problem 22 22
Compatibility Problem 22 22
Unstable 22 22
Corroded 20 37
Fitting Problem 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5634 5714
Non-union Bone Fracture 3055 3209
Pain 2322 2354
Insufficient Information 2202 2264
Failure of Implant 1799 1834
No Code Available 1741 1741
Unspecified Infection 1668 1675
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1014 1014
Foreign Body In Patient 928 931
Bone Fracture(s) 792 806
Injury 537 537
Post Operative Wound Infection 536 538
No Consequences Or Impact To Patient 464 464
Unspecified Tissue Injury 382 382
Loss of Range of Motion 352 352
Discomfort 348 355
Hypersensitivity/Allergic reaction 341 341
Implant Pain 302 325
Malunion of Bone 298 327
Skin Inflammation/ Irritation 282 282
No Known Impact Or Consequence To Patient 261 264
Physical Asymmetry 261 261
Necrosis 256 311
Impaired Healing 254 258
Swelling/ Edema 199 202
Nerve Damage 190 190
Wound Dehiscence 170 170
Device Embedded In Tissue or Plaque 142 146
Muscular Rigidity 127 132
No Information 117 117
Arthritis 112 118
Inflammation 111 111
Deformity/ Disfigurement 108 109
Hematoma 95 95
Foreign Body Reaction 89 89
Numbness 86 90
Muscle/Tendon Damage 83 83
Ambulation Difficulties 81 81
Osteolysis 76 77
Reaction 75 77
Distress 71 71
Fall 68 68
Inadequate Osseointegration 65 65
Joint Dislocation 64 64
Adhesion(s) 58 58
Hip Fracture 54 54
Limb Fracture 51 68
No Patient Involvement 51 51
Abscess 50 50
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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