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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
A.M. SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACTIVORTHO, INC
  SUBSTANTIALLY EQUIVALENT 1
ACTIVORTHO, INC.
  SUBSTANTIALLY EQUIVALENT 1
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 9
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASCENSION ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
AZURMEDS INC.
  SUBSTANTIALLY EQUIVALENT 2
BESPA GLOBAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIEDERMANN MEDTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
CHM SP. Z O.O.
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTEMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CURVAFIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIAMOND ORTHOPEDIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIC EXTREMITY, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXSOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXSOMED HOLDING COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXSOMED HOLDINGS COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXSOMED, CORP.
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 3
FIELD ORTHOPAEDICS PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
FLOWER ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 3
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 5
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLW MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GRAMERCY EXTREMITY ORTHOPEIDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ICONN ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 2
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INION OY
  SUBSTANTIALLY EQUIVALENT 1
INNOVATE ORTHOPAEDICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDSHAPE INC
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 2
MERETE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEOORTHO PRODUTOS ORTOPEDICOS S/A
  SUBSTANTIALLY EQUIVALENT 1
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 2
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 8
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 3
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SOLUTIONS UK LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
OSSIO LTD.
  SUBSTANTIALLY EQUIVALENT 2
OSTEOCENTRIC EXTREMITIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
OSTEOCENTRIC TRAUMA
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED LLC
  SUBSTANTIALLY EQUIVALENT 2
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 4
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADICLE ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPONSIVE ARTHROSCOPY LLC
  SUBSTANTIALLY EQUIVALENT 2
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
RETROFIX SCREWS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SAFETYFIX MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMV SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 4
STUCKENBROCK MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SUBCHONDRAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SUBCHONDRAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGTECH INC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC / DEPUY ORTHOPAEDICS INC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES USA PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
TDM CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
VILEX IN TENNESSEE, INC
  SUBSTANTIALLY EQUIVALENT 1
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 7

MDR Year MDR Reports MDR Events
2017 2559 2559
2018 3657 3657
2019 5459 5463
2020 4817 4820
2021 4444 4507

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8707 8707
Break 4483 4553
Migration 1090 1090
Device-Device Incompatibility 1052 1052
Fracture 799 799
Insufficient Information 472 472
Material Twisted/Bent 404 404
No Apparent Adverse Event 384 384
Migration or Expulsion of Device 329 329
Unintended Movement 309 309
Appropriate Term/Code Not Available 306 306
Device Slipped 267 267
Device Dislodged or Dislocated 245 245
Material Fragmentation 212 212
Entrapment of Device 188 188
Detachment of Device or Device Component 175 175
Material Separation 165 165
Difficult to Remove 161 161
Positioning Failure 156 156
Loose or Intermittent Connection 153 153
Patient-Device Incompatibility 147 147
Loss of Osseointegration 134 134
Material Deformation 132 132
Device Operates Differently Than Expected 126 126
Manufacturing, Packaging or Shipping Problem 114 114
Corroded 101 101
Loosening of Implant Not Related to Bone-Ingrowth 97 97
Crack 95 95
Patient Device Interaction Problem 89 89
Mechanical Problem 70 70
Difficult to Advance 70 70
Difficult to Insert 65 65
Detachment Of Device Component 63 63
Malposition of Device 61 61
Failure to Align 61 61
Failure to Advance 61 61
Bent 55 55
Use of Device Problem 50 50
Mechanical Jam 47 47
Positioning Problem 46 46
Material Integrity Problem 45 45
Osseointegration Problem 43 43
Unstable 37 37
Packaging Problem 37 37
Improper or Incorrect Procedure or Method 36 36
Physical Resistance/Sticking 33 33
Inadequacy of Device Shape and/or Size 32 32
Failure To Adhere Or Bond 31 31
Fitting Problem 31 31
Component Missing 31 31
Material Split, Cut or Torn 31 31
Material Protrusion/Extrusion 29 29
Dull, Blunt 23 23
Loss of or Failure to Bond 23 23
Material Frayed 23 23
Noise, Audible 23 23
Naturally Worn 22 22
Defective Device 21 21
Device Markings/Labelling Problem 21 21
Biocompatibility 19 19
Material Discolored 19 19
Material Erosion 18 18
Therapeutic or Diagnostic Output Failure 18 18
Separation Failure 17 17
Incomplete or Missing Packaging 13 13
Device Damaged by Another Device 13 13
Compatibility Problem 13 13
Degraded 13 13
Failure to Osseointegrate 12 12
Failure to Cut 12 12
Device Difficult to Maintain 12 12
Device Contamination with Chemical or Other Material 11 11
Activation, Positioning or SeparationProblem 11 11
Peeled/Delaminated 10 10
Nonstandard Device 9 9
Sticking 9 9
Flaked 9 9
Device Handling Problem 9 9
Difficult or Delayed Positioning 8 8
Delivered as Unsterile Product 8 8
Difficult To Position 8 8
Device Contaminated During Manufacture or Shipping 8 8
Defective Component 8 8
Device Damaged Prior to Use 7 7
Contamination /Decontamination Problem 7 7
Incorrect, Inadequate or Imprecise Resultor Readings 7 7
Unsealed Device Packaging 7 7
Collapse 7 7
Material Disintegration 7 7
Scratched Material 7 7
Inaccurate Information 7 7
Unexpected Therapeutic Results 6 6
Metal Shedding Debris 6 6
Mechanics Altered 6 6
Connection Problem 5 5
Tear, Rip or Hole in Device Packaging 5 5
Deformation Due to Compressive Stress 5 5
Device Inoperable 5 5
Off-Label Use 5 5
Firing Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 5517 5517
Pain 2692 2692
Unspecified Infection 2223 2224
Non-union Bone Fracture 2152 2152
No Known Impact Or Consequence To Patient 1751 1758
Failure of Implant 1587 1587
No Clinical Signs, Symptoms or Conditions 1443 1504
No Consequences Or Impact To Patient 1442 1442
Bone Fracture(s) 971 971
Injury 819 819
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 640 640
No Information 637 637
Foreign Body In Patient 501 507
Impaired Healing 498 498
Post Operative Wound Infection 400 400
Discomfort 359 359
Device Embedded In Tissue or Plaque 344 344
Loss of Range of Motion 299 299
Necrosis 297 297
Insufficient Information 291 291
Hypersensitivity/Allergic reaction 270 270
Not Applicable 261 261
Reaction 239 239
Swelling 220 220
No Patient Involvement 192 192
Nerve Damage 174 174
Tissue Damage 149 149
Irritation 136 136
Arthritis 133 133
Unspecified Tissue Injury 131 131
Inflammation 120 120
Inadequate Osseointegration 115 115
Osteolysis 107 107
Wound Dehiscence 107 107
Physical Asymmetry 93 93
Implant Pain 81 81
Dysphagia/ Odynophagia 71 71
Skin Inflammation/ Irritation 70 70
Limited Mobility Of The Implanted Joint 68 68
Hip Fracture 67 67
Skin Irritation 66 66
Ossification 64 64
Malunion of Bone 61 61
Hematoma 58 58
Patient Problem/Medical Problem 57 57
Rash 54 54
Paralysis 54 54
Scar Tissue 52 52
Neurological Deficit/Dysfunction 52 52
Joint Dislocation 52 52
Numbness 52 52
Ambulation Difficulties 51 51
Bacterial Infection 45 45
Erythema 42 42
Fall 39 39
Spinal Column Injury 39 39
Swelling/ Edema 39 39
Purulent Discharge 36 36
Muscular Rigidity 35 35
Foreign Body Reaction 34 34
Calcium Deposits/Calcification 34 34
Ulcer 33 33
Hypoesthesia 31 31
Death 28 28
Joint Disorder 26 26
Weakness 26 26
Difficulty Chewing 25 25
Cyst(s) 24 24
Abscess 23 23
Rupture 23 23
Muscle/Tendon Damage 22 22
Adhesion(s) 21 21
Cerebrospinal Fluid Leakage 20 20
Thrombosis 20 20
Erosion 19 19
Itching Sensation 18 18
Synovitis 18 18
Visual Impairment 17 17
Fever 17 17
Headache 17 17
Metal Related Pathology 17 17
Blood Loss 17 17
Sleep Dysfunction 16 16
Fistula 16 16
Fatigue 16 16
Neuropathy 15 15
Tingling 15 15
Deformity/ Disfigurement 15 15
Sedation 13 13
Perforation 13 13
Edema 13 13
Osteopenia/ Osteoporosis 13 13
Intervertebral Disc Compression or Protrusion 13 13
Joint Laxity 12 12
Inadequate Pain Relief 12 12
Cardiac Arrest 12 12
Cellulitis 11 11
Scarring 11 11
Staphylococcus Aureus 10 10
Sepsis 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Mar-17-2020
2 Biomet II Jun-09-2020
3 Biomet, Inc. II Dec-17-2020
4 Cayenne Medical Inc. II Jul-10-2018
5 CrossRoads Extremity Systems, LLC II Oct-24-2019
6 DePuy Mitek, Inc., a Johnson & Johnson Co. II Jun-20-2017
7 In2bones USA, LLC II Aug-21-2018
8 Integra Limited II Apr-05-2019
9 Medshape, INC. II Jan-04-2022
10 MicroPort Orthopedics Inc. II Oct-11-2018
11 Nextremity Solutions II Apr-27-2021
12 Nextremity Solutions II Feb-24-2020
13 Nextremity Solutions II Jan-03-2020
14 ORTHO SOLUTIONS, LTD. II Mar-09-2018
15 PROVIDENCE MEDICAL TECHNOLOGIES II Jun-25-2020
16 Smith & Nephew, Inc. II Oct-19-2021
17 Smith & Nephew, Inc. II Mar-20-2018
18 Smith & Nephew, Inc. II Apr-18-2017
19 Stryker Corporation II Mar-02-2018
20 Synthes (USA) Products LLC II Oct-24-2018
21 Trilliant Surgical Ltd. II Jan-06-2017
22 Trilliant Surgical, LLC II Mar-30-2020
23 Wright Medical Technology, Inc. II Nov-25-2019
24 Zimmer Biomet, Inc. II Nov-07-2019
25 Zimmer Biomet, Inc. II May-09-2019
26 Zimmer Biomet, Inc. II Sep-14-2018
27 Zimmer Biomet, Inc. II May-08-2018
28 Zimmer Biomet, Inc. II Mar-15-2018
29 Zimmer Biomet, Inc. II Feb-16-2017
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