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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 7
ACUMED LLC
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
ADDITIVE ORTHOPAEDICS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
  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
BIOMEDICAL ENTERPRISES, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICOFIXATION
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 4
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BONEBRIDGE AG
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 3
CARBOFIX ORTHOPEDICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CITIEFFE S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CONVENTUS ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTEMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 3
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 8
ENDEAVOR ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIC EXTREMITY, LLC
  SUBSTANTIALLY EQUIVALENT 3
EXSOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 3
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 2
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 LTD
  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 2
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 9
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 15
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
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1
LEITH MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 2
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, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIAMI DEVICE SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 5
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 2
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SOLUTIONS UK LTD
  SUBSTANTIALLY EQUIVALENT 2
ORTHOCARE
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIATRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 2
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 4
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 12
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 11
STUCKENBROCK MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 4
TDM CO. LTD.
  SUBSTANTIALLY EQUIVALENT 3
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 2
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
TRIDENT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TRILLIANT SURGICAL, LTD
  SUBSTANTIALLY EQUIVALENT 2
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 8
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2275 2275
2017 2216 2216
2018 2662 2662
2019 3356 3356
2020 2791 2791
2021 1864 1864

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6014 6014
Break 3094 3094
Fracture 1091 1091
Device-Device Incompatibility 426 426
Insufficient Information 423 423
Migration or Expulsion of Device 402 402
Appropriate Term/Code Not Available 353 353
Migration 351 351
Device Operates Differently Than Expected 233 233
Device Slipped 195 195
No Apparent Adverse Event 185 185
Device Dislodged or Dislocated 169 169
Material Twisted/Bent 159 159
Patient-Device Incompatibility 137 137
Packaging Problem 134 134
Fitting Problem 119 119
Material Fragmentation 115 115
Difficult to Remove 114 114
Loose or Intermittent Connection 106 106
Unintended Movement 100 100
Material Deformation 91 91
Physical Resistance/Sticking 91 91
Detachment of Device or Device Component 91 91
Corroded 84 84
Detachment Of Device Component 80 80
Mechanical Problem 76 76
Positioning Failure 76 76
Difficult to Insert 75 75
Device Inoperable 71 71
Use of Device Problem 69 69
Manufacturing, Packaging or Shipping Problem 68 68
Positioning Problem 63 63
Bent 60 60
Loosening of Implant Not Related to Bone-Ingrowth 60 60
Malposition of Device 57 57
Entrapment of Device 56 56
Separation Failure 53 53
Crack 52 52
Inadequacy of Device Shape and/or Size 50 50
Improper or Incorrect Procedure or Method 50 50
Connection Problem 49 49
Osseointegration Problem 49 49
Component Missing 48 48
Failure to Align 43 43
Material Discolored 41 41
Delivered as Unsterile Product 38 38
Dull, Blunt 37 37
Device Contamination with Chemical or Other Material 36 36
Mechanics Altered 36 36
Failure To Adhere Or Bond 36 36
Device Markings/Labelling Problem 34 34
Defective Device 34 34
Patient Device Interaction Problem 33 33
Unstable 32 32
Device Contaminated During Manufacture or Shipping 31 31
Failure to Osseointegrate 30 30
Noise, Audible 27 27
Material Integrity Problem 27 27
Metal Shedding Debris 26 26
Naturally Worn 23 23
Mechanical Jam 22 22
Unsealed Device Packaging 20 20
Off-Label Use 19 19
Disassembly 19 19
Sharp Edges 19 19
Tear, Rip or Hole in Device Packaging 18 18
Material Separation 18 18
Device Packaging Compromised 17 17
Loss of Osseointegration 16 16
Sticking 15 15
Degraded 13 13
Separation Problem 13 13
Therapeutic or Diagnostic Output Failure 12 12
Defective Component 12 12
Failure to Advance 11 11
Torn Material 11 11
Nonstandard Device 11 11
Difficult To Position 10 10
Material Protrusion/Extrusion 10 10
Device Expiration Issue 9 9
Loss of or Failure to Bond 9 9
Device Damaged by Another Device 9 9
Contamination /Decontamination Problem 9 9
Device Difficult to Maintain 9 9
Peeled/Delaminated 9 9
Component Falling 9 9
Fail-Safe Design Failure 8 8
Biocompatibility 8 8
Device Operational Issue 8 8
Premature Activation 8 8
Flaked 7 7
Material Rupture 7 7
Misconnection 6 6
Difficult to Advance 6 6
Device Or Device Fragments Location Unknown 6 6
Deformation Due to Compressive Stress 6 6
Component or Accessory Incompatibility 6 6
Split 6 6
Device Handling Problem 6 6
Overheating of Device 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 3972 3972
Pain 1941 1941
Non-union Bone Fracture 1638 1638
No Known Impact Or Consequence To Patient 1522 1522
Failure of Implant 1515 1515
Unspecified Infection 1375 1375
Bone Fracture(s) 872 872
Impaired Healing 781 781
No Information 737 737
No Consequences Or Impact To Patient 678 678
No Clinical Signs, Symptoms or Conditions 629 629
Injury 611 611
Discomfort 372 372
Loss of Range of Motion 305 305
No Patient Involvement 300 300
Device Embedded In Tissue or Plaque 239 239
Necrosis 221 221
Post Operative Wound Infection 210 210
Foreign Body In Patient 202 203
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 195 195
Swelling 189 189
Nerve Damage 169 169
Insufficient Information 119 119
Hypersensitivity/Allergic reaction 118 118
Irritation 117 117
Arthritis 113 113
Reaction 111 111
Fall 96 96
Wound Dehiscence 92 92
Osteolysis 72 72
Skin Irritation 70 70
Inflammation 63 63
Physical Asymmetry 62 62
Hematoma 61 61
Tissue Damage 60 60
Malunion of Bone 56 56
Not Applicable 54 54
Hypoesthesia 52 52
Implant Pain 49 49
Hemorrhage/Bleeding 46 47
Dysphagia/ Odynophagia 46 46
Limited Mobility Of The Implanted Joint 45 45
Patient Problem/Medical Problem 44 44
Skin Inflammation/ Irritation 42 42
Joint Dislocation 41 41
Rash 37 37
Ossification 37 37
Inadequate Osseointegration 34 34
Rupture 34 34
Calcium Deposits/Calcification 33 33
Death 33 33
Bacterial Infection 29 29
Unspecified Tissue Injury 28 28
Swelling/ Edema 27 27
Adhesion(s) 27 27
Pneumothorax 24 24
Fracture, Arm 24 24
Deformity/ Disfigurement 22 22
Erythema 22 22
Neuropathy 22 22
Itching Sensation 22 22
Cellulitis 22 22
Laceration(s) 21 21
Muscular Rigidity 21 21
Sepsis 20 20
Sedation 20 20
Abscess 19 19
Cerebrospinal Fluid Leakage 19 19
Erosion 19 19
Joint Disorder 18 18
Weakness 17 17
Foreign Body Reaction 17 17
Ambulation Difficulties 17 17
Fistula 16 16
Chest Pain 16 16
Visual Impairment 15 15
Blood Loss 15 15
Muscle/Tendon Damage 15 15
Thrombosis 15 15
Numbness 14 14
Fatigue 13 13
Tingling 13 13
Paralysis 13 13
Pocket Erosion 13 13
Burning Sensation 12 12
Edema 12 12
Eye Injury 12 12
Missing Value Reason 11 11
Metal Related Pathology 11 11
Fever 10 10
Staphylococcus Aureus 10 10
Skin Erosion 10 10
Skin Infection 10 10
Complaint, Ill-Defined 10 10
Purulent Discharge 10 10
Scar Tissue 10 10
Pneumonia 9 9
Headache 9 9
Skin Discoloration 9 9
Neurological Deficit/Dysfunction 9 9

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 Arthrex, Inc. II Apr-08-2016
5 Biomet II Jun-09-2020
6 Biomet, Inc. II Jan-21-2021
7 Biomet, Inc. II May-26-2016
8 Epic Extremity, LLC II May-15-2018
9 Flower Orthopedics Corporation II Oct-06-2021
10 Flower Orthopedics Corporation II Aug-12-2020
11 I.T.S. GmbH II Jun-04-2019
12 In2Bones, SAS II Aug-03-2017
13 In2Bones, SAS II Jan-06-2017
14 Integra LifeSciences Corp. II Jun-14-2016
15 K2M, Inc II Apr-12-2021
16 Miami Device Solutions, LLC. II Dec-05-2019
17 NewDeal SA II Jul-16-2018
18 Nextremity Solutions II Feb-11-2020
19 Nextremity Solutions II Nov-22-2019
20 Orthofix, Inc II Jun-07-2018
21 Smith & Nephew, Inc. II Sep-09-2020
22 Smith & Nephew, Inc. II Jan-24-2018
23 Smith & Nephew, Inc. II Jan-19-2018
24 Smith & Nephew, Inc. II Apr-18-2017
25 Smith & Nephew, Inc. II Apr-14-2017
26 Stryker GmbH II Jan-07-2020
27 Synthes (USA) Products LLC II Aug-17-2020
28 Synthes (USA) Products LLC II Aug-11-2016
29 Synthes (USA) Products LLC II Jun-10-2016
30 Synthes, Inc. II Jan-29-2020
31 Toby Orthopaedics, Inc. II Dec-04-2019
32 TriMed Inc. II Nov-13-2019
33 TriMed Inc. II Oct-10-2019
34 TriMed Inc. II Apr-23-2019
35 TriMed Inc. II Aug-18-2018
36 Trimed Inc II Sep-20-2016
37 Wishbone Medical, Inc. II Jun-04-2021
38 Wright Medical Technology, Inc. II Nov-25-2019
39 Zimmer Biomet, Inc. II Nov-07-2019
40 Zimmer Biomet, Inc. II Aug-31-2018
41 Zimmer Biomet, Inc. II Apr-03-2018
42 Zimmer Biomet, Inc. II Jan-14-2016
43 Zimmer Manufacturing B.V. II Mar-12-2016
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