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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 plate, fixation, bone
Product CodeHRS
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 1
AAP IMPLANTATE AG
  SUBSTANTIALLY EQUIVALENT 4
ACUMED LLC
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
ADDITIVE ORTHOPAEDICS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 11
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
AVANTI ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICOFIXATION
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 3
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BONEBRIDGE AG
  SUBSTANTIALLY EQUIVALENT 2
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 2
CARBOFIX ORTHOPEDICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CITIEFFE S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTEMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 9
ENDEAVOR ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIC EXTREMITY, LLC
  SUBSTANTIALLY EQUIVALENT 2
EXREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
EXSOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 3
FIELD ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
FIXIER, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
FUSION INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
GENESIS FRACTURE CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 6
GLW MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERCIO LTDA
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERICO LTDA.
  SUBSTANTIALLY EQUIVALENT 1
GPC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GRAHAM MEDICAL TECHNOLOGIES, L.L.C. DBA GRAMEDICA
  SUBSTANTIALLY EQUIVALENT 1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
GREENS SURGICALS PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
I.T.S. GMBH
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 12
IN2BONESUSA, LLC
  SUBSTANTIALLY EQUIVALENT 2
INDUSTRIAS MEDICAS SAMPEDRO S.A.S
  SUBSTANTIALLY EQUIVALENT 1
INTAI TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JACE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 13
JIANGSU TRAUHUI MEDICAL INSTRUMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
JM LONGYEAR MANUFACTURING, LLC D.B.A. ABLE MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
JM LONGYEAR MANUFACTURING, LLC D/B/A ABLE MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN LP
  SUBSTANTIALLY EQUIVALENT 1
LEITH MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXXION MEDICAL, LLC / BAUMER SA
  SUBSTANTIALLY EQUIVALENT 1
MCGINLEY ORTHPAEDIC INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 10
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIAMI DEVICE SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 3
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
MX ORTHOPEDICS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
NARANG MEDICAL USA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NEBULA SURGICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 10
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 4
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 2
ORTHO SOLUTIONS UK LTD
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
PANTHEON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 4
PEGA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC D.B.A RESOLVE SURGICAL TECH
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC., DBA RTI SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
S H PITKAR ORTHOTOOLS PVT LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIG MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIG MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 9
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 12
STUCKENBROCK MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 4
TDM CO. LTD.
  SUBSTANTIALLY EQUIVALENT 3
TECHFIT DIGITAL SURGERY INC.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 2
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
TRIDENT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
TRILLIANT SURGICAL, LTD
  SUBSTANTIALLY EQUIVALENT 1
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRUEMED GROUP LLC
  SUBSTANTIALLY EQUIVALENT 2
TRUEMED GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
VILEX LLC
  SUBSTANTIALLY EQUIVALENT 1
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 7
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 2216 2216
2018 2662 2662
2019 3356 3356
2020 2791 2791
2021 2448 2448
2022 1052 1055

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6108 6110
Break 2731 2733
Fracture 1081 1083
Device-Device Incompatibility 519 519
Migration 414 414
Insufficient Information 352 352
Appropriate Term/Code Not Available 346 346
Migration or Expulsion of Device 304 304
No Apparent Adverse Event 184 184
Material Twisted/Bent 183 183
Device Slipped 165 165
Device Dislodged or Dislocated 139 139
Packaging Problem 137 137
Patient-Device Incompatibility 129 129
Device Operates Differently Than Expected 123 123
Use of Device Problem 100 100
Material Deformation 99 99
Difficult to Remove 97 97
Detachment of Device or Device Component 95 95
Physical Resistance/Sticking 92 92
Corroded 91 91
Positioning Failure 88 88
Loose or Intermittent Connection 84 84
Loosening of Implant Not Related to Bone-Ingrowth 75 75
Material Fragmentation 73 73
Manufacturing, Packaging or Shipping Problem 71 71
Mechanical Problem 70 70
Unintended Movement 64 64
Entrapment of Device 63 63
Osseointegration Problem 61 61
Fitting Problem 58 58
Malposition of Device 54 54
Device Inoperable 54 54
Difficult to Insert 53 53
Crack 51 51
Detachment Of Device Component 51 51
Separation Failure 51 51
Inadequacy of Device Shape and/or Size 48 48
Delivered as Unsterile Product 46 46
Patient Device Interaction Problem 46 46
Improper or Incorrect Procedure or Method 44 44
Positioning Problem 43 43
Connection Problem 42 42
Bent 42 42
Device Contaminated During Manufacture or Shipping 40 40
Defective Device 39 39
Component Missing 38 38
Material Discolored 37 37
Unstable 33 33
Failure to Align 32 32
Material Integrity Problem 31 31
Device Markings/Labelling Problem 29 29
Failure To Adhere Or Bond 26 26
Tear, Rip or Hole in Device Packaging 25 25
Mechanics Altered 24 24
Noise, Audible 23 23
Off-Label Use 22 22
Device Contamination with Chemical or Other Material 21 21
Unsealed Device Packaging 20 20
Naturally Worn 19 19
Dull, Blunt 19 19
Failure to Osseointegrate 19 19
Sharp Edges 19 19
Mechanical Jam 18 18
Disassembly 17 17
Loss of Osseointegration 16 16
Device Packaging Compromised 15 15
Contamination /Decontamination Problem 14 14
Metal Shedding Debris 13 13
Degraded 13 13
Separation Problem 13 13
Incomplete or Inadequate Connection 11 11
Device Damaged by Another Device 11 11
Material Protrusion/Extrusion 10 10
Sticking 10 10
Nonstandard Device 10 10
Material Separation 10 10
Therapeutic or Diagnostic Output Failure 10 10
Device Difficult to Maintain 9 9
Component Falling 9 9
Deformation Due to Compressive Stress 9 9
Biocompatibility 9 9
Failure to Advance 8 8
Loss of or Failure to Bond 8 8
Fail-Safe Design Failure 8 8
Flaked 8 8
Premature Activation 8 8
Peeled/Delaminated 7 7
Difficult To Position 7 7
Device Operational Issue 7 7
Output Problem 6 6
Split 6 6
Device Or Device Fragments Location Unknown 5 5
Difficult to Advance 5 5
Misconnection 5 5
Unexpected Therapeutic Results 5 5
Material Rupture 5 5
Material Erosion 5 5
Device Expiration Issue 5 5
Device Handling Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 3292 3292
Pain 1776 1776
Non-union Bone Fracture 1587 1588
Failure of Implant 1338 1340
Unspecified Infection 1256 1256
No Known Impact Or Consequence To Patient 1076 1076
No Clinical Signs, Symptoms or Conditions 1020 1020
Bone Fracture(s) 916 917
No Consequences Or Impact To Patient 643 643
Impaired Healing 604 604
Injury 587 587
No Information 574 574
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 416 416
Discomfort 347 347
Loss of Range of Motion 317 317
Post Operative Wound Infection 292 292
No Patient Involvement 285 285
Necrosis 269 269
Foreign Body In Patient 233 233
Insufficient Information 213 213
Nerve Damage 195 195
Device Embedded In Tissue or Plaque 163 163
Swelling 154 154
Hypersensitivity/Allergic reaction 130 130
Arthritis 128 128
Physical Asymmetry 125 125
Malunion of Bone 103 103
Reaction 97 97
Irritation 95 95
Wound Dehiscence 94 94
Implant Pain 87 87
Osteolysis 77 77
Fall 77 77
Skin Irritation 68 68
Hematoma 61 61
Tissue Damage 59 59
Inflammation 56 56
Not Applicable 54 54
Skin Inflammation/ Irritation 53 53
Swelling/ Edema 52 52
Hypoesthesia 52 52
Unspecified Tissue Injury 48 48
Hemorrhage/Bleeding 47 48
Dysphagia/ Odynophagia 47 47
Patient Problem/Medical Problem 44 44
Joint Dislocation 43 43
Limited Mobility Of The Implanted Joint 37 37
Muscular Rigidity 37 37
Ossification 36 36
Rash 34 34
Inadequate Osseointegration 34 34
Calcium Deposits/Calcification 33 33
Adhesion(s) 29 29
Deformity/ Disfigurement 29 29
Rupture 27 27
Bacterial Infection 26 26
Pneumothorax 25 25
Muscle/Tendon Damage 23 23
Cellulitis 22 22
Cerebrospinal Fluid Leakage 22 22
Erythema 22 22
Neuropathy 21 21
Laceration(s) 21 21
Sepsis 21 21
Death 20 20
Metal Related Pathology 19 19
Fracture, Arm 19 19
Ambulation Difficulties 18 18
Erosion 18 18
Chest Pain 17 17
Abscess 17 17
Numbness 17 17
Joint Disorder 16 16
Fistula 16 16
Foreign Body Reaction 16 16
Visual Impairment 15 15
Itching Sensation 15 15
Thrombosis 14 14
Weakness 14 14
Eye Injury 14 14
Blood Loss 14 14
Fatigue 13 13
Scar Tissue 13 13
Paralysis 13 13
Pocket Erosion 13 13
Burning Sensation 12 12
Tingling 12 12
Skin Erosion 11 11
Local Reaction 11 11
Osteopenia/ Osteoporosis 11 11
Skin Infection 11 11
Missing Value Reason 11 11
Limb Fracture 11 11
Complaint, Ill-Defined 10 10
Visual Disturbances 10 10
Skin Discoloration 10 10
Fever 10 10
Edema 10 10
Purulent Discharge 10 10
Headache 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Feb-14-2017
2 Arthrex, Inc. II Apr-09-2021
3 Arthrex, Inc. II Jul-29-2020
4 Biomet II Jun-09-2020
5 Biomet, Inc. II Jan-21-2021
6 Epic Extremity, LLC II May-15-2018
7 Flower Orthopedics Corporation II Oct-06-2021
8 Flower Orthopedics Corporation II Aug-12-2020
9 I.T.S. GmbH II Jun-04-2019
10 In2Bones, SAS II Aug-03-2017
11 In2Bones, SAS II Jan-06-2017
12 K2M, Inc II Apr-12-2021
13 Miami Device Solutions, LLC. II Dec-05-2019
14 NewDeal SA II Jul-16-2018
15 Nextremity Solutions II Feb-11-2020
16 Nextremity Solutions II Nov-22-2019
17 Orthofix, Inc II Jun-07-2018
18 Paragon 28, Inc. II Jul-25-2022
19 Smith & Nephew, Inc. II Feb-01-2022
20 Smith & Nephew, Inc. II Dec-10-2021
21 Smith & Nephew, Inc. II Nov-18-2021
22 Smith & Nephew, Inc. II Sep-09-2020
23 Smith & Nephew, Inc. II Jan-24-2018
24 Smith & Nephew, Inc. II Jan-19-2018
25 Smith & Nephew, Inc. II Apr-18-2017
26 Smith & Nephew, Inc. II Apr-14-2017
27 Stryker GmbH II Jan-07-2020
28 Synthes (USA) Products LLC II Aug-17-2020
29 Synthes, Inc. II Jan-29-2020
30 Toby Orthopaedics, Inc. II Dec-04-2019
31 TriMed Inc. II Nov-13-2019
32 TriMed Inc. II Oct-10-2019
33 TriMed Inc. II Apr-23-2019
34 TriMed Inc. II Aug-18-2018
35 Wishbone Medical, Inc. II Jun-04-2021
36 Wright Medical Technology Inc II Dec-17-2021
37 Wright Medical Technology, Inc. II Mar-15-2022
38 Wright Medical Technology, Inc. II Feb-25-2022
39 Wright Medical Technology, Inc. II Dec-20-2021
40 Wright Medical Technology, Inc. II Nov-25-2019
41 Zimmer Biomet, Inc. II Nov-07-2019
42 Zimmer Biomet, Inc. II Aug-31-2018
43 Zimmer Biomet, Inc. II Apr-03-2018
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