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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
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 2
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 4
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 2
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 1
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 1172 1172

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5625 5625
Break 2999 2999
Fracture 1064 1064
Insufficient Information 419 419
Migration or Expulsion of Device 399 399
Device-Device Incompatibility 383 383
Appropriate Term/Code Not Available 334 334
Migration 302 302
Device Operates Differently Than Expected 233 233
Device Slipped 187 187
No Apparent Adverse Event 181 181
Device Dislodged or Dislocated 164 164
Material Twisted/Bent 141 141
Patient-Device Incompatibility 136 136
Packaging Problem 131 131
Fitting Problem 119 119
Material Fragmentation 114 114
Difficult to Remove 113 113
Loose or Intermittent Connection 104 104
Unintended Movement 100 100
Physical Resistance/Sticking 91 91
Detachment of Device or Device Component 90 90
Corroded 84 84
Detachment Of Device Component 80 80
Material Deformation 79 79
Mechanical Problem 75 75
Positioning Failure 71 71
Device Inoperable 71 71
Difficult to Insert 70 70
Manufacturing, Packaging or Shipping Problem 64 64
Use of Device Problem 63 63
Positioning Problem 62 62
Bent 60 60
Loosening of Implant Not Related to Bone-Ingrowth 59 59
Malposition of Device 56 56
Separation Failure 53 53
Entrapment of Device 51 51
Improper or Incorrect Procedure or Method 50 50
Crack 50 50
Inadequacy of Device Shape and/or Size 49 49
Connection Problem 48 48
Osseointegration Problem 48 48
Component Missing 46 46
Failure to Align 42 42
Material Discolored 40 40
Dull, Blunt 37 37
Device Contamination with Chemical or Other Material 36 36
Mechanics Altered 36 36
Failure To Adhere Or Bond 36 36
Delivered as Unsterile Product 35 35
Defective Device 34 34
Device Markings/Labelling Problem 33 33
Unstable 32 32
Patient Device Interaction Problem 32 32
Failure to Osseointegrate 30 30
Device Contaminated During Manufacture or Shipping 30 30
Metal Shedding Debris 26 26
Noise, Audible 26 26
Mechanical Jam 22 22
Material Integrity Problem 22 22
Naturally Worn 21 21
Disassembly 19 19
Unsealed Device Packaging 19 19
Off-Label Use 19 19
Sharp Edges 19 19
Material Separation 18 18
Device Packaging Compromised 17 17
Tear, Rip or Hole in Device Packaging 15 15
Sticking 15 15
Loss of Osseointegration 14 14
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 1868 1868
Non-union Bone Fracture 1528 1528
No Known Impact Or Consequence To Patient 1522 1522
Failure of Implant 1472 1472
Unspecified Infection 1366 1366
Bone Fracture(s) 803 803
Impaired Healing 762 762
No Information 737 737
No Consequences Or Impact To Patient 678 678
Injury 611 611
No Clinical Signs, Symptoms or Conditions 494 494
Discomfort 349 349
No Patient Involvement 300 300
Loss of Range of Motion 299 299
Device Embedded In Tissue or Plaque 239 239
Necrosis 216 216
Foreign Body In Patient 192 193
Swelling 189 189
Nerve Damage 158 158
Post Operative Wound Infection 148 148
Irritation 117 117
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 114 114
Reaction 111 111
Hypersensitivity/Allergic reaction 106 106
Arthritis 100 100
Fall 90 90
Wound Dehiscence 87 87
Insufficient Information 86 86
Osteolysis 72 72
Skin Irritation 70 70
Inflammation 60 60
Tissue Damage 60 60
Hematoma 55 55
Not Applicable 54 54
Hypoesthesia 52 52
Physical Asymmetry 46 46
Limited Mobility Of The Implanted Joint 45 45
Hemorrhage/Bleeding 45 46
Patient Problem/Medical Problem 44 44
Implant Pain 44 44
Dysphagia/ Odynophagia 41 41
Rash 37 37
Joint Dislocation 35 35
Rupture 34 34
Inadequate Osseointegration 34 34
Ossification 33 33
Death 33 33
Calcium Deposits/Calcification 33 33
Adhesion(s) 27 27
Malunion of Bone 27 27
Bacterial Infection 24 24
Pneumothorax 24 24
Fracture, Arm 24 24
Erythema 22 22
Itching Sensation 22 22
Cellulitis 21 21
Swelling/ Edema 21 21
Neuropathy 21 21
Deformity/ Disfigurement 21 21
Sedation 20 20
Laceration(s) 20 20
Muscular Rigidity 20 20
Unspecified Tissue Injury 19 19
Erosion 19 19
Joint Disorder 18 18
Weakness 17 17
Foreign Body Reaction 17 17
Abscess 17 17
Sepsis 17 17
Ambulation Difficulties 17 17
Cerebrospinal Fluid Leakage 16 16
Chest Pain 16 16
Fistula 15 15
Visual Impairment 15 15
Blood Loss 15 15
Thrombosis 15 15
Tingling 13 13
Paralysis 13 13
Pocket Erosion 13 13
Burning Sensation 12 12
Edema 12 12
Numbness 12 12
Metal Related Pathology 11 11
Fatigue 11 11
Eye Injury 11 11
Missing Value Reason 11 11
Skin Infection 10 10
Complaint, Ill-Defined 10 10
Purulent Discharge 10 10
Scar Tissue 10 10
Fever 10 10
Staphylococcus Aureus 10 10
Skin Erosion 10 10
Muscle/Tendon Damage 10 10
Ulcer 9 9
Skin Discoloration 9 9
Neurological Deficit/Dysfunction 9 9
Pneumonia 9 9
Headache 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 Aug-12-2020
10 I.T.S. GmbH II Jun-04-2019
11 In2Bones, SAS II Aug-03-2017
12 In2Bones, SAS II Jan-06-2017
13 Integra LifeSciences Corp. II Jun-14-2016
14 K2M, Inc II Apr-12-2021
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 Orthofix, Inc II Jun-07-2018
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 (USA) Products LLC II Aug-11-2016
28 Synthes (USA) Products LLC II Jun-10-2016
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 Trimed Inc II Sep-20-2016
36 Wishbone Medical, Inc. II Jun-04-2021
37 Wright Medical Technology, Inc. II Nov-25-2019
38 Zimmer Biomet, Inc. II Nov-07-2019
39 Zimmer Biomet, Inc. II Aug-31-2018
40 Zimmer Biomet, Inc. II Apr-03-2018
41 Zimmer Biomet, Inc. II Jan-14-2016
42 Zimmer Manufacturing B.V. II Mar-12-2016
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