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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 6
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ACUMED LLC
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
ADVANCED ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 12
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL ENTERPRISES, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL ENTERPRISES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 8
BIOMET INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 6
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 5
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
CITIEFFE S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CONVENTUS ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 4
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 6
EMINENT SPINE
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 3
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 2
FLEXTRONICS INTERNATIONAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
FUSION ORTHOPEDICS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
FX SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
GENESIS FRACTURE CARE, INC.
  SUBSTANTIALLY EQUIVALENT 4
GLOBUS
  SUBSTANTIALLY EQUIVALENT 3
GPC MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 2
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 8
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 14
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
KLS MARTIN GMBH and CO. KG
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 3
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 12
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE, INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIAMI DEVICE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NARANG MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NARANG MEDICAL USA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 10
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 3
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 3
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 2
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 1
PEGA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 11
SMV SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 15
STRYKER TRAUMA AG
  SUBSTANTIALLY EQUIVALENT 1
STUCKENBROCK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC / MEDICAL DEVICE BUSINESS SERVICE
  SUBSTANTIALLY EQUIVALENT 4
SYNTHES USA
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 2
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 6
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRUEMED GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
TRUEMED GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 11
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 6
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2015 3091 3091
2016 2272 2272
2017 2215 2215
2018 2662 2662
2019 3356 3356
2020 2062 2062

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5871 5871
Break 3434 3434
Fracture 1063 1063
Screw 933 933
Plate 550 550
Migration or Expulsion of Device 511 511
Insufficient Information 503 503
Appropriate Term/Code Not Available 376 376
Device Operates Differently Than Expected 373 373
Device-Device Incompatibility 262 262
Migration 251 251
Device Dislodged or Dislocated 225 225
Device Slipped 222 222
Fitting Problem 204 204
No Apparent Adverse Event 180 180
Patient-Device Incompatibility 157 157
Difficult to Remove 147 147
Loose or Intermittent Connection 141 141
Packaging Problem 130 130
Material Fragmentation 118 118
Unintended Movement 116 116
Tip 110 110
Detachment Of Device Component 107 107
Difficult to Insert 103 103
Crack 102 102
Bent 100 100
Detachment of Device or Device Component 98 98
Malposition of Device 89 89
Physical Resistance/Sticking 89 89
Material Twisted/Bent 86 86
Corroded 80 80
Mechanical Problem 77 77
Positioning Problem 76 76
Device Inoperable 73 73
Material Deformation 70 70
Failure To Adhere Or Bond 69 69
Manufacturing, Packaging or Shipping Problem 62 62
Improper or Incorrect Procedure or Method 60 60
Screw Head 54 54
Shaft 53 53
Separation Failure 52 52
Dull, Blunt 51 51
Component Missing 50 50
Positioning Failure 49 49
Failure to Align 48 48
Device Markings/Labelling Problem 48 48
Inadequacy of Device Shape and/or Size 47 47
Entrapment of Device 47 47
Use of Device Problem 47 47
Mechanics Altered 46 46
Material Discolored 43 43
Device Contamination with Chemical or Other Material 42 42
Metal Shedding Debris 42 42
Connection Problem 41 41
Osseointegration Problem 40 40
Failure to Osseointegrate 36 36
Loosening of Implant Not Related to Bone-Ingrowth 35 35
Lock 35 35
Delivered as Unsterile Product 31 31
Mechanical Jam 31 31
Component or Accessory Incompatibility 27 27
Noise, Audible 26 26
Defective Device 26 26
Heads 26 26
Device Contaminated During Manufacture or Shipping 26 26
Sticking 24 24
Driver 23 23
Loss of Osseointegration 22 22
Patient Device Interaction Problem 22 22
Material Integrity Problem 21 21
Thread 20 20
Disassembly 19 19
Sharp Edges 19 19
Unstable 19 19
Material Perforation 18 18
Off-Label Use 18 18
Device Packaging Compromised 18 18
Unsealed Device Packaging 17 17
Component Falling 17 17
Pin 16 16
Material Separation 16 16
Degraded 15 15
Wire 15 15
Compatibility Problem 15 15
Loss of or Failure to Bond 14 14
Torn Material 13 13
Material Rupture 13 13
Failure to Advance 13 13
Locking Mechanism 12 12
Device Damaged by Another Device 12 12
Material Protrusion/Extrusion 12 12
Separation Problem 11 11
Device Expiration Issue 11 11
Difficult To Position 11 11
Defective Component 11 11
Difficult to Advance 10 10
Naturally Worn 10 10
Therapeutic or Diagnostic Output Failure 10 10
Device Handling Problem 9 9
Device Or Device Fragments Location Unknown 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 4453 4453
Pain 2190 2190
No Known Impact Or Consequence To Patient 1991 1991
Non-union Bone Fracture 1711 1711
Failure of Implant 1663 1663
Unspecified Infection 1592 1592
Impaired Healing 985 985
No Information 851 851
Bone Fracture(s) 800 800
No Consequences Or Impact To Patient 693 693
Injury 571 571
Discomfort 367 367
Loss of Range of Motion 339 339
Device Embedded In Tissue or Plaque 321 321
No Patient Involvement 301 301
Necrosis 238 238
Swelling 218 218
Foreign Body In Patient 182 182
Reaction 155 155
Irritation 153 153
Nerve Damage 128 128
Fall 118 118
Wound Dehiscence 113 113
Post Operative Wound Infection 97 97
Arthritis 94 94
Hematoma 83 83
Sedation 82 82
Hypersensitivity/Allergic reaction 74 74
Tissue Damage 73 73
Osteolysis 70 70
Inflammation 67 67
Skin Irritation 62 62
Limited Mobility Of The Implanted Joint 58 58
Not Applicable 54 54
Hypoesthesia 54 54
Hemorrhage/Bleeding 51 51
Rupture 50 50
Ossification 48 48
Joint Dislocation 45 45
Patient Problem/Medical Problem 44 44
Death 39 39
Inadequate Osseointegration 36 36
Rash 36 36
Calcium Deposits/Calcification 36 36
Perforation 35 35
Dysphagia/ Odynophagia 33 33
Erosion 28 28
Fracture, Arm 28 28
Joint Disorder 27 27
Cellulitis 23 23
No Clinical Signs, Symptoms or Conditions 23 23
Neuropathy 22 22
Thrombosis 21 21
Laceration(s) 21 21
Pneumothorax 21 21
Complaint, Ill-Defined 21 21
Itching Sensation 20 20
Adhesion(s) 20 20
Erythema 20 20
Foreign Body Reaction 19 19
Weakness 19 19
Bacterial Infection 18 18
Blood Loss 18 18
Deformity/ Disfigurement 18 18
Abscess 17 17
Cerebrospinal Fluid Leakage 16 16
Sepsis 16 16
Chest Pain 16 16
Visual Impairment 15 15
Tingling 15 15
Neurological Deficit/Dysfunction 15 15
Numbness 15 15
Ambulation Difficulties 15 15
Fistula 14 14
Pocket Erosion 13 13
Paralysis 13 13
Staphylococcus Aureus 13 13
Scar Tissue 12 12
Scarring 12 12
Eye Injury 12 12
Edema 12 12
Synovitis 11 11
Missing Value Reason 11 11
Muscular Rigidity 10 10
Fever 10 10
Skin Erosion 10 10
Ulcer 9 9
Collapse 9 9
Fatigue 9 9
Skin Discoloration 9 9
Pneumonia 9 9
Joint Swelling 9 9
Fibrosis 8 8
Urinary Tract Infection 8 8
Embolism 8 8
Septic Shock 8 8
Cyst(s) 8 8
Pulmonary Embolism 8 8
Dyspnea 7 7
Renal Failure 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Feb-14-2017
2 Arthrex, Inc. II Jul-29-2020
3 Arthrex, Inc. II Apr-08-2016
4 Biomet II Jun-09-2020
5 Biomet, Inc. II May-26-2016
6 Biomet, Inc. II Dec-18-2015
7 Biomet, Inc. II Jul-10-2015
8 Biomet, Inc. II Jul-08-2015
9 Epic Extremity, LLC II May-15-2018
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 Miami Device Solutions, LLC. II Dec-05-2019
16 NewDeal SA II Jul-16-2018
17 Nextremity Solutions II Feb-11-2020
18 Nextremity Solutions II Nov-22-2019
19 OrthoPediatrics Corp II Sep-18-2015
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 Smith & Nephew, Inc. II Dec-04-2015
27 Stryker GmbH II Jan-07-2020
28 Synthes (USA) Products LLC II Aug-17-2020
29 Synthes (USA) Products LLC II Aug-11-2016
30 Synthes (USA) Products LLC II Jun-10-2016
31 Synthes (USA) Products LLC II Nov-06-2015
32 Synthes (USA) Products LLC II Oct-30-2015
33 Synthes (USA) Products LLC II Oct-15-2015
34 Synthes, Inc. II Jan-29-2020
35 Toby Orthopaedics, Inc. II Dec-04-2019
36 TriMed Inc. II Nov-13-2019
37 TriMed Inc. II Oct-10-2019
38 TriMed Inc. II Apr-23-2019
39 TriMed Inc. II Aug-18-2018
40 Trilliant Surgical Ltd. II Sep-04-2015
41 Trilliant Surgical Ltd. II Aug-31-2015
42 Trimed Inc II Sep-20-2016
43 Wright Medical Technology, Inc. II Nov-25-2019
44 Wright Medical Technology, Inc. II Sep-01-2015
45 Wright Medical Technology, Inc. II Apr-22-2015
46 Zimmer Biomet, Inc. II Nov-07-2019
47 Zimmer Biomet, Inc. II Aug-31-2018
48 Zimmer Biomet, Inc. II Apr-03-2018
49 Zimmer Biomet, Inc. II Jan-14-2016
50 Zimmer Manufacturing B.V. II Mar-12-2016
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