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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device plate, fixation, bone
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeHRS
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
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 8
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHROSURFACE, INC.
  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
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BONEBRIDGE AG
  SUBSTANTIALLY EQUIVALENT 1
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 8
ENDEAVOR ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIC EXTREMITY, LLC
  SUBSTANTIALLY EQUIVALENT 2
EXSOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 3
FIELD ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
GENESIS FRACTURE CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 5
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
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 11
IN2BONESUSA, LLC
  SUBSTANTIALLY EQUIVALENT 2
INDUSTRIAS MEDICAS SAMPEDRO S.A.S
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JACE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 12
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
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
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 9
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 1
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 2
PEGA MEDICAL INC.
  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 10
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
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 2
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
TRIDENT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
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
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 2431 2431

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5647 5647
Break 2479 2479
Fracture 969 969
Device-Device Incompatibility 455 455
Migration 376 376
Insufficient Information 346 346
Appropriate Term/Code Not Available 336 336
Migration or Expulsion of Device 296 296
No Apparent Adverse Event 182 182
Material Twisted/Bent 172 172
Device Slipped 157 157
Packaging Problem 137 137
Device Dislodged or Dislocated 136 136
Patient-Device Incompatibility 125 125
Device Operates Differently Than Expected 123 123
Physical Resistance/Sticking 91 91
Difficult to Remove 90 90
Detachment of Device or Device Component 87 87
Corroded 84 84
Use of Device Problem 82 82
Positioning Failure 81 81
Loose or Intermittent Connection 80 80
Material Deformation 79 79
Manufacturing, Packaging or Shipping Problem 70 70
Mechanical Problem 68 68
Material Fragmentation 67 67
Loosening of Implant Not Related to Bone-Ingrowth 62 62
Unintended Movement 61 61
Entrapment of Device 56 56
Osseointegration Problem 55 55
Fitting Problem 55 55
Device Inoperable 54 54
Difficult to Insert 53 53
Detachment Of Device Component 51 51
Separation Failure 51 51
Crack 48 48
Inadequacy of Device Shape and/or Size 48 48
Malposition of Device 45 45
Improper or Incorrect Procedure or Method 43 43
Bent 42 42
Patient Device Interaction Problem 42 42
Connection Problem 41 41
Positioning Problem 40 40
Device Contaminated During Manufacture or Shipping 40 40
Component Missing 37 37
Material Discolored 37 37
Delivered as Unsterile Product 37 37
Defective Device 34 34
Unstable 33 33
Failure to Align 32 32
Device Markings/Labelling Problem 29 29
Failure To Adhere Or Bond 26 26
Material Integrity Problem 25 25
Mechanics Altered 24 24
Noise, Audible 23 23
Device Contamination with Chemical or Other Material 21 21
Tear, Rip or Hole in Device Packaging 21 21
Dull, Blunt 19 19
Failure to Osseointegrate 19 19
Naturally Worn 19 19
Unsealed Device Packaging 19 19
Sharp Edges 19 19
Off-Label Use 18 18
Mechanical Jam 18 18
Disassembly 17 17
Loss of Osseointegration 16 16
Device Packaging Compromised 15 15
Degraded 13 13
Metal Shedding Debris 13 13
Separation Problem 13 13
Therapeutic or Diagnostic Output Failure 10 10
Sticking 10 10
Material Separation 10 10
Device Damaged by Another Device 10 10
Material Protrusion/Extrusion 10 10
Contamination /Decontamination Problem 9 9
Nonstandard Device 9 9
Component Falling 9 9
Device Difficult to Maintain 9 9
Loss of or Failure to Bond 8 8
Fail-Safe Design Failure 8 8
Premature Activation 8 8
Biocompatibility 8 8
Failure to Advance 8 8
Device Operational Issue 7 7
Peeled/Delaminated 7 7
Difficult To Position 7 7
Flaked 7 7
Split 6 6
Deformation Due to Compressive Stress 6 6
Device Or Device Fragments Location Unknown 5 5
Difficult to Advance 5 5
Material Erosion 5 5
Device Expiration Issue 5 5
Misconnection 5 5
Material Rupture 5 5
Pressure Problem 5 5
Device Handling Problem 5 5
Missing Value Reason 4 4
Difficult or Delayed Separation 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 3292 3292
Pain 1702 1702
Non-union Bone Fracture 1444 1444
Failure of Implant 1218 1218
Unspecified Infection 1183 1183
No Known Impact Or Consequence To Patient 1076 1076
Bone Fracture(s) 850 850
No Clinical Signs, Symptoms or Conditions 761 761
No Consequences Or Impact To Patient 643 643
Injury 587 587
Impaired Healing 586 586
No Information 574 574
Discomfort 335 335
No Patient Involvement 285 285
Loss of Range of Motion 284 284
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 258 258
Post Operative Wound Infection 242 242
Necrosis 233 233
Foreign Body In Patient 193 193
Nerve Damage 172 172
Device Embedded In Tissue or Plaque 161 161
Insufficient Information 155 155
Swelling 154 154
Arthritis 117 117
Hypersensitivity/Allergic reaction 115 115
Reaction 97 97
Irritation 95 95
Wound Dehiscence 85 85
Physical Asymmetry 82 82
Malunion of Bone 80 80
Osteolysis 73 73
Fall 73 73
Skin Irritation 68 68
Implant Pain 63 63
Tissue Damage 59 59
Hematoma 58 58
Not Applicable 54 54
Inflammation 53 53
Hypoesthesia 52 52
Dysphagia/ Odynophagia 47 47
Skin Inflammation/ Irritation 46 46
Hemorrhage/Bleeding 45 46
Patient Problem/Medical Problem 44 44
Joint Dislocation 40 40
Swelling/ Edema 40 40
Limited Mobility Of The Implanted Joint 37 37
Unspecified Tissue Injury 35 35
Rash 34 34
Calcium Deposits/Calcification 33 33
Inadequate Osseointegration 33 33
Ossification 30 30
Adhesion(s) 29 29
Rupture 27 27
Bacterial Infection 26 26
Pneumothorax 24 24
Muscular Rigidity 24 24
Cellulitis 22 22
Erythema 22 22
Deformity/ Disfigurement 22 22
Neuropathy 21 21
Laceration(s) 21 21
Sepsis 21 21
Death 20 20
Cerebrospinal Fluid Leakage 19 19
Fracture, Arm 19 19
Muscle/Tendon Damage 18 18
Erosion 18 18
Abscess 17 17
Ambulation Difficulties 17 17
Joint Disorder 16 16
Chest Pain 16 16
Fistula 15 15
Foreign Body Reaction 15 15
Visual Impairment 15 15
Itching Sensation 15 15
Weakness 14 14
Thrombosis 14 14
Blood Loss 14 14
Pocket Erosion 13 13
Scar Tissue 13 13
Paralysis 13 13
Fatigue 13 13
Eye Injury 12 12
Burning Sensation 12 12
Tingling 12 12
Skin Erosion 11 11
Missing Value Reason 11 11
Numbness 11 11
Metal Related Pathology 11 11
Skin Infection 11 11
Complaint, Ill-Defined 10 10
Skin Discoloration 10 10
Edema 10 10
Fever 10 10
Purulent Discharge 10 10
Pulmonary Embolism 8 8
Headache 8 8
Urinary Tract Infection 8 8
Local Reaction 8 8
Neurological Deficit/Dysfunction 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 Smith & Nephew, Inc. II Dec-10-2021
19 Smith & Nephew, Inc. II Nov-18-2021
20 Smith & Nephew, Inc. II Sep-09-2020
21 Smith & Nephew, Inc. II Jan-24-2018
22 Smith & Nephew, Inc. II Jan-19-2018
23 Smith & Nephew, Inc. II Apr-18-2017
24 Smith & Nephew, Inc. II Apr-14-2017
25 Stryker GmbH II Jan-07-2020
26 Synthes (USA) Products LLC II Aug-17-2020
27 Synthes, Inc. II Jan-29-2020
28 Toby Orthopaedics, Inc. II Dec-04-2019
29 TriMed Inc. II Nov-13-2019
30 TriMed Inc. II Oct-10-2019
31 TriMed Inc. II Apr-23-2019
32 TriMed Inc. II Aug-18-2018
33 Wishbone Medical, Inc. II Jun-04-2021
34 Wright Medical Technology Inc II Dec-17-2021
35 Wright Medical Technology, Inc. II Dec-20-2021
36 Wright Medical Technology, Inc. II Nov-25-2019
37 Zimmer Biomet, Inc. II Nov-07-2019
38 Zimmer Biomet, Inc. II Aug-31-2018
39 Zimmer Biomet, Inc. II Apr-03-2018
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