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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
ACUMED LLC
  SUBSTANTIALLY EQUIVALENT 1
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 9
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
AVANTI ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
  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 2
DIAMOND ORTHOPEDIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
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
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLW MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
GLW, INC.
  SUBSTANTIALLY EQUIVALENT 1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ICONN ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INION OY
  SUBSTANTIALLY EQUIVALENT 1
INNOVATE ORTHOPAEDICS LIMITED
  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 1
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE INC
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 9
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 3
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCIRCLE SPINE D.B.A. OC MEDICAL DEVICES
  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 3
OSTEOCENTRIC EXTREMITIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
OSTEOCENTRIC TRAUMA
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED LLC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 5
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
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 5
STUCKENBROCK MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SUBCHONDRAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC / DEPUY ORTHOPAEDICS INC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES USA PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TDM 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
VILEX IN TENNESSEE, INC
  SUBSTANTIALLY EQUIVALENT 1
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 1
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2018 3658 3658
2019 5459 5463
2020 4817 4820
2021 4461 4524
2022 3969 4323

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9502 9782
Break 4755 4829
Migration 1452 1511
Device-Device Incompatibility 1316 1316
Fracture 822 826
Material Twisted/Bent 419 419
No Apparent Adverse Event 411 411
Insufficient Information 370 370
Device Slipped 315 315
Appropriate Term/Code Not Available 275 275
Entrapment of Device 275 275
Migration or Expulsion of Device 272 272
Device Dislodged or Dislocated 258 269
Unintended Movement 207 207
Detachment of Device or Device Component 201 201
Patient Device Interaction Problem 195 195
Positioning Failure 186 186
Material Separation 173 173
Patient-Device Incompatibility 146 146
Material Deformation 139 139
Material Fragmentation 137 137
Manufacturing, Packaging or Shipping Problem 131 131
Difficult to Remove 130 130
Loss of Osseointegration 118 118
Loosening of Implant Not Related to Bone-Ingrowth 116 116
Loose or Intermittent Connection 114 114
Crack 99 99
Corroded 94 94
Difficult to Advance 76 76
Use of Device Problem 71 71
Mechanical Problem 69 69
Difficult to Insert 61 61
Material Integrity Problem 60 60
Device Operates Differently Than Expected 56 56
Failure to Advance 54 54
Malposition of Device 53 53
Failure to Align 49 49
Positioning Problem 44 44
Osseointegration Problem 43 43
Mechanical Jam 38 38
Improper or Incorrect Procedure or Method 36 36
Physical Resistance/Sticking 36 36
Unstable 33 33
Material Split, Cut or Torn 33 33
Packaging Problem 30 30
Defective Device 29 29
Bent 28 28
Inadequacy of Device Shape and/or Size 27 27
Detachment Of Device Component 27 27
Fitting Problem 23 23
Material Protrusion/Extrusion 23 23
Component Missing 23 23
Material Frayed 22 22
Device Markings/Labelling Problem 21 21
Naturally Worn 21 21
Therapeutic or Diagnostic Output Failure 20 20
Loss of or Failure to Bond 19 19
Biocompatibility 19 19
Failure to Cut 18 18
Tear, Rip or Hole in Device Packaging 18 18
Material Discolored 17 17
Compatibility Problem 16 16
Noise, Audible 15 15
Material Erosion 15 15
Dull, Blunt 14 14
Incomplete or Missing Packaging 13 13
Device Damaged by Another Device 12 12
Device Contaminated During Manufacture or Shipping 12 12
Failure To Adhere Or Bond 12 12
Device Difficult to Maintain 12 12
Activation, Positioning or Separation Problem 12 12
Separation Failure 11 11
Inaccurate Information 11 11
Failure to Osseointegrate 10 10
Degraded 10 10
Delivered as Unsterile Product 10 10
Flaked 9 9
Contamination /Decontamination Problem 9 9
Nonstandard Device 9 9
Device Handling Problem 9 9
Peeled/Delaminated 8 8
Difficult or Delayed Positioning 8 8
Device Damaged Prior to Use 8 8
Defective Component 7 7
Unexpected Therapeutic Results 7 7
Material Disintegration 6 6
Collapse 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Output Problem 6 6
Separation Problem 5 5
Structural Problem 5 5
Deformation Due to Compressive Stress 5 5
Firing Problem 5 5
Scratched Material 5 5
Mechanics Altered 5 5
Off-Label Use 5 5
Expiration Date Error 5 5
Device Appears to Trigger Rejection 5 5
Device Contamination with Chemical or Other Material 5 5
Product Quality Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 4825 4825
Pain 2686 2688
No Clinical Signs, Symptoms or Conditions 2556 2636
Non-union Bone Fracture 2444 2588
Unspecified Infection 2300 2300
Failure of Implant 1598 1614
No Consequences Or Impact To Patient 1358 1358
No Known Impact Or Consequence To Patient 1177 1184
Bone Fracture(s) 1000 1014
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 994 994
Injury 797 797
Foreign Body In Patient 641 647
Insufficient Information 541 570
No Information 475 475
Post Operative Wound Infection 464 464
Impaired Healing 421 421
Discomfort 386 386
Necrosis 342 397
Loss of Range of Motion 339 339
Hypersensitivity/Allergic reaction 307 307
Unspecified Tissue Injury 271 271
Not Applicable 253 253
Device Embedded In Tissue or Plaque 241 241
Nerve Damage 214 214
Reaction 193 193
Swelling 179 179
No Patient Involvement 174 174
Arthritis 140 144
Wound Dehiscence 135 135
Physical Asymmetry 133 133
Inflammation 130 130
Implant Pain 130 152
Tissue Damage 127 127
Malunion of Bone 126 149
Inadequate Osseointegration 120 120
Irritation 112 112
Skin Inflammation/ Irritation 110 110
Osteolysis 105 106
Swelling/ Edema 78 78
Hematoma 77 77
Joint Dislocation 72 72
Numbness 71 71
Dysphagia/ Odynophagia 69 69
Ossification 68 68
Hip Fracture 66 66
Skin Irritation 62 62
Patient Problem/Medical Problem 57 57
Ambulation Difficulties 56 56
Muscle/Tendon Damage 56 56
Paralysis 55 55
Scar Tissue 53 53
Rash 50 50
Neurological Deficit/Dysfunction 49 49
Bacterial Infection 48 48
Limited Mobility Of The Implanted Joint 43 43
Foreign Body Reaction 40 40
Abscess 40 40
Spinal Column Injury 37 37
Unspecified Nervous System Problem 36 36
Fall 35 35
Calcium Deposits/Calcification 35 35
Purulent Discharge 35 35
Erythema 34 34
Ulcer 34 38
Rupture 34 34
Metal Related Pathology 33 33
Deformity/ Disfigurement 31 32
Hypoesthesia 31 31
Muscular Rigidity 30 30
Limb Fracture 30 47
Adhesion(s) 28 28
Fistula 27 27
Weakness 26 26
Fatigue 26 26
Joint Disorder 26 26
Cyst(s) 24 24
Death 23 23
Difficulty Chewing 22 22
Osteopenia/ Osteoporosis 22 22
Cerebrospinal Fluid Leakage 20 20
Joint Laxity 20 20
Thrombosis 20 20
Erosion 19 19
Thrombosis/Thrombus 18 18
Neuropathy 18 18
Synovitis 18 18
Blood Loss 17 17
Visual Impairment 17 17
Inadequate Pain Relief 16 16
Fluid Discharge 16 16
Headache 16 16
Sleep Dysfunction 16 16
Perforation 15 15
Sepsis 15 15
Tingling 15 15
Hemorrhage/Bleeding 14 14
Itching Sensation 14 14
Intervertebral Disc Compression or Protrusion 13 13
Skin Erosion 13 13
Cardiac Arrest 12 12

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 Cayenne Medical Inc. II Jul-10-2018
7 CrossRoads Extremity Systems, LLC II Oct-24-2019
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 Stryker Corporation II Mar-02-2018
23 Synthes (USA) Products LLC II Oct-24-2018
24 Trilliant Surgical, LLC II Mar-30-2020
25 Wright Medical Technology, Inc. II Nov-25-2019
26 Zimmer Biomet, Inc. II Nov-07-2019
27 Zimmer Biomet, Inc. II May-09-2019
28 Zimmer Biomet, Inc. II Sep-14-2018
29 Zimmer Biomet, Inc. II May-08-2018
30 Zimmer Biomet, Inc. II Mar-15-2018
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