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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
AAP IMPLANTATE AG
  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
ARTHREX, 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
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
FLOWER ORTHOPEDICS CORPORATION DBA CONVENTUS FLOWER ORTHO
  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 2
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 5
OSTEOCENTRIC EXTREMITIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 4
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
TIGON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TRAX SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS INC.
  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 3934 4288
2023 3737 3737
2024 3191 3191

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10877 11157
Break 5475 5549
Migration 2074 2133
Device-Device Incompatibility 1792 1792
Fracture 868 872
Material Twisted/Bent 520 520
Entrapment of Device 460 460
No Apparent Adverse Event 459 459
Device Slipped 380 380
Insufficient Information 304 304
Device Dislodged or Dislocated 294 305
Positioning Failure 236 236
Patient Device Interaction Problem 234 234
Appropriate Term/Code Not Available 224 224
Detachment of Device or Device Component 208 208
Material Deformation 204 204
Migration or Expulsion of Device 201 201
Loosening of Implant Not Related to Bone-Ingrowth 201 201
Manufacturing, Packaging or Shipping Problem 195 195
Patient-Device Incompatibility 191 191
Material Fragmentation 180 180
Material Separation 174 174
Unintended Movement 156 156
Difficult to Advance 142 142
Difficult to Remove 123 123
Use of Device Problem 109 109
Loss of Osseointegration 105 105
Material Integrity Problem 86 86
Crack 85 85
Loose or Intermittent Connection 67 67
Difficult to Insert 59 59
Failure to Advance 58 58
Mechanical Jam 56 56
Corroded 52 52
Mechanical Problem 50 50
Improper or Incorrect Procedure or Method 48 48
Defective Device 47 47
Osseointegration Problem 45 45
Physical Resistance/Sticking 44 44
Positioning Problem 42 42
Material Split, Cut or Torn 39 39
Malposition of Device 37 37
Unstable 33 33
Fitting Problem 30 30
Device Contaminated During Manufacture or Shipping 29 29
Inadequacy of Device Shape and/or Size 26 26
Failure to Align 26 26
Tear, Rip or Hole in Device Packaging 26 26
Compatibility Problem 24 24
Off-Label Use 23 23

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4551 4631
No Code Available 4010 4010
Non-union Bone Fracture 3210 3354
Pain 2926 2928
Unspecified Infection 2374 2374
Failure of Implant 1926 1942
Insufficient Information 1726 1755
Bone Fracture(s) 1037 1051
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1002 1002
Foreign Body In Patient 912 918
No Consequences Or Impact To Patient 883 883
Injury 735 735
No Known Impact Or Consequence To Patient 697 704
Post Operative Wound Infection 541 541
Loss of Range of Motion 461 461
Discomfort 459 459
Necrosis 401 456
Impaired Healing 373 373
Unspecified Tissue Injury 353 353
Hypersensitivity/Allergic reaction 345 345
No Information 278 278
Implant Pain 258 280
Skin Inflammation/ Irritation 256 256
Malunion of Bone 248 271
Nerve Damage 248 248
Physical Asymmetry 232 232
Device Embedded In Tissue or Plaque 203 203
Wound Dehiscence 201 201
Swelling/ Edema 182 182
Arthritis 148 152
Reaction 139 139
No Patient Involvement 135 135
Inflammation 127 127
Not Applicable 126 126
Hematoma 123 123
Muscular Rigidity 123 123
Swelling 102 102
Tissue Damage 102 102
Osteolysis 102 103
Inadequate Osseointegration 100 100
Deformity/ Disfigurement 94 95
Numbness 93 93
Ambulation Difficulties 89 89
Foreign Body Reaction 88 88
Muscle/Tendon Damage 81 81
Ossification 78 78
Joint Dislocation 75 75
Distress 75 75
Irritation 74 74
Scar Tissue 70 70

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