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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device screw, fixation, bone
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 10
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
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
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 CORP.
  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 2
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
MAXXION MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE INC
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 2
MERETE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MICROWARE PRECISION CO., LTD.
  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 2
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
  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
RELJA INNOVATIONS, LLC
  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
SIGNUS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SMV SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 6
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 4461 4524
2022 2292 2646

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9618 9898
Break 5139 5213
Migration 1289 1348
Device-Device Incompatibility 1219 1219
Fracture 881 885
Insufficient Information 493 493
Material Twisted/Bent 450 450
No Apparent Adverse Event 400 400
Migration or Expulsion of Device 334 334
Unintended Movement 328 328
Appropriate Term/Code Not Available 311 311
Device Slipped 309 309
Device Dislodged or Dislocated 269 280
Entrapment of Device 247 247
Material Fragmentation 223 223
Detachment of Device or Device Component 198 198
Positioning Failure 169 169
Difficult to Remove 169 169
Material Separation 165 165
Patient-Device Incompatibility 159 159
Loose or Intermittent Connection 157 157
Material Deformation 150 150
Loss of Osseointegration 135 135
Device Operates Differently Than Expected 126 126
Manufacturing, Packaging or Shipping Problem 124 124
Corroded 106 106
Loosening of Implant Not Related to Bone-Ingrowth 105 105
Crack 102 102
Patient Device Interaction Problem 90 90
Difficult to Advance 75 75
Mechanical Problem 73 73
Difficult to Insert 66 66
Malposition of Device 64 64
Detachment Of Device Component 63 63
Failure to Align 62 62
Failure to Advance 61 61
Use of Device Problem 58 58
Material Integrity Problem 58 58
Bent 55 55
Mechanical Jam 53 53
Positioning Problem 46 46
Osseointegration Problem 43 43
Unstable 42 42
Packaging Problem 38 38
Improper or Incorrect Procedure or Method 36 36
Physical Resistance/Sticking 35 35
Fitting Problem 34 34
Inadequacy of Device Shape and/or Size 33 33
Material Split, Cut or Torn 33 33
Failure To Adhere Or Bond 31 31
Component Missing 31 31
Defective Device 29 29
Material Protrusion/Extrusion 29 29
Material Frayed 24 24
Loss of or Failure to Bond 23 23
Dull, Blunt 23 23
Noise, Audible 23 23
Naturally Worn 22 22
Device Markings/Labelling Problem 22 22
Biocompatibility 19 19
Material Discolored 19 19
Therapeutic or Diagnostic Output Failure 19 19
Material Erosion 18 18
Tear, Rip or Hole in Device Packaging 18 18
Separation Failure 17 17
Compatibility Problem 14 14
Failure to Cut 14 14
Degraded 14 14
Device Damaged by Another Device 13 13
Incomplete or Missing Packaging 13 13
Failure to Osseointegrate 12 12
Device Contaminated During Manufacture or Shipping 12 12
Activation, Positioning or SeparationProblem 12 12
Device Difficult to Maintain 12 12
Device Contamination with Chemical or Other Material 11 11
Defective Component 10 10
Peeled/Delaminated 10 10
Nonstandard Device 9 9
Delivered as Unsterile Product 9 9
Sticking 9 9
Difficult or Delayed Positioning 9 9
Flaked 9 9
Contamination /Decontamination Problem 9 9
Device Handling Problem 9 9
Inaccurate Information 8 8
Device Damaged Prior to Use 8 8
Difficult To Position 8 8
Unsealed Device Packaging 7 7
Unexpected Therapeutic Results 7 7
Incorrect, Inadequate or Imprecise Resultor Readings 7 7
Material Disintegration 7 7
Collapse 7 7
Scratched Material 7 7
Off-Label Use 6 6
Product Quality Problem 6 6
Metal Shedding Debris 6 6
Mechanics Altered 6 6
Connection Problem 5 5
Structural Problem 5 5
Deformation Due to Compressive Stress 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 5517 5517
Pain 2864 2866
Non-union Bone Fracture 2460 2604
Unspecified Infection 2438 2439
No Clinical Signs, Symptoms or Conditions 2124 2204
No Known Impact Or Consequence To Patient 1751 1758
Failure of Implant 1726 1742
No Consequences Or Impact To Patient 1442 1442
Bone Fracture(s) 1038 1052
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 954 954
Injury 819 819
No Information 637 637
Foreign Body In Patient 614 620
Impaired Healing 504 504
Post Operative Wound Infection 437 437
Insufficient Information 388 417
Discomfort 387 387
Device Embedded In Tissue or Plaque 354 354
Necrosis 330 385
Loss of Range of Motion 323 323
Hypersensitivity/Allergic reaction 293 293
Not Applicable 261 261
Reaction 239 239
Swelling 220 220
Unspecified Tissue Injury 215 215
Nerve Damage 197 197
No Patient Involvement 192 192
Tissue Damage 149 149
Arthritis 138 142
Irritation 136 136
Inflammation 131 131
Wound Dehiscence 125 125
Physical Asymmetry 120 120
Implant Pain 119 141
Inadequate Osseointegration 117 117
Osteolysis 112 113
Malunion of Bone 105 128
Skin Inflammation/ Irritation 87 87
Numbness 78 78
Ossification 76 76
Hematoma 74 74
Dysphagia/ Odynophagia 71 71
Joint Dislocation 68 68
Limited Mobility Of The Implanted Joint 68 68
Hip Fracture 67 67
Skin Irritation 66 66
Swelling/ Edema 65 65
Ambulation Difficulties 59 59
Patient Problem/Medical Problem 57 57
Paralysis 55 55
Rash 54 54
Scar Tissue 52 52
Neurological Deficit/Dysfunction 52 52
Bacterial Infection 49 49
Fall 45 45
Erythema 42 42
Spinal Column Injury 39 39
Foreign Body Reaction 38 38
Purulent Discharge 36 36
Muscular Rigidity 35 35
Ulcer 35 39
Calcium Deposits/Calcification 34 34
Muscle/Tendon Damage 32 32
Hypoesthesia 31 31
Deformity/ Disfigurement 29 30
Death 28 28
Cyst(s) 27 27
Rupture 26 26
Weakness 26 26
Joint Disorder 26 26
Difficulty Chewing 25 25
Abscess 25 25
Fatigue 24 24
Adhesion(s) 23 23
Fistula 22 22
Cerebrospinal Fluid Leakage 21 21
Metal Related Pathology 21 21
Thrombosis 20 20
Erosion 19 19
Fever 18 18
Itching Sensation 18 18
Synovitis 18 18
Neuropathy 18 18
Visual Impairment 17 17
Headache 17 17
Joint Laxity 17 17
Blood Loss 17 17
Sleep Dysfunction 16 16
Tingling 15 15
Perforation 14 14
Osteopenia/ Osteoporosis 14 14
Sedation 13 13
Inadequate Pain Relief 13 13
Intervertebral Disc Compression or Protrusion 13 13
Fluid Discharge 13 13
Hemorrhage/Bleeding 13 13
Edema 13 13
Cardiac Arrest 12 12
Limb Fracture 12 29
Cellulitis 11 11

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