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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
Product CodeHRS
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
A PLUS BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
AAP IMPLANTATE AG
  SUBSTANTIALLY EQUIVALENT 5
ACUMED LLC
  SUBSTANTIALLY EQUIVALENT 2
ADDITIVE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 12
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 4
AVANTI ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MICOFIXATION
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 3
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
BONEBRIDGE AG
  SUBSTANTIALLY EQUIVALENT 3
CARBOFIX ORTHOPEDICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTEMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 3
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 8
DOUBLE MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
ENDEAVOR ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIC EXTREMITY, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 1
EXREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
EXSOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 2
FIELD ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
FIXIER, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
FORMA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUSION INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
GLW MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERCIO LTDA
  SUBSTANTIALLY EQUIVALENT 3
GM DOS REIS INDUSTRIA E COMERICO LTDA.
  SUBSTANTIALLY EQUIVALENT 1
GPC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
HANKIL TECH MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HOSPITAL EQUIPMENT MANUFACTURING COMPANY
  SUBSTANTIALLY EQUIVALENT 1
I.T.S. GMBH
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 10
INDUSTRIAS MEDICAS SAMPEDRO S.A.S
  SUBSTANTIALLY EQUIVALENT 1
INTAI TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTRAUMA S.P.A
  SUBSTANTIALLY EQUIVALENT 1
JACE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
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 2
KLS MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 3
LEITH MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
MAXXION MEDICAL, LLC / BAUMER SA
  SUBSTANTIALLY EQUIVALENT 1
MCGINLEY ORTHPAEDIC INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 12
MEDLINE INDUSTIRES, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEBULA SURGICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 4
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 2
ORTHO LIFE SYSTEMS PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SOLUTIONS UK LTD
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 5
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 CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS INC
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SKY SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 5
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 10
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES GMBH
  SUBSTANTIALLY EQUIVALENT 1
TDM CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
TDM CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TECHFIT DIGITAL SURGERY INC.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS INC.
  SUBSTANTIALLY EQUIVALENT 2
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
TRIMED, INC
  SUBSTANTIALLY EQUIVALENT 1
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
TRUEMED GROUP LLC
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 4
VILEX LLC
  SUBSTANTIALLY EQUIVALENT 3
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 3356 3356
2020 2790 2790
2021 2443 2443
2022 1700 1703
2023 2058 2058
2024 1064 1065

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6389 6392
Break 2159 2161
Fracture 1039 1041
Device-Device Incompatibility 660 660
Migration 587 587
Insufficient Information 281 281
Appropriate Term/Code Not Available 245 245
No Apparent Adverse Event 209 209
Material Twisted/Bent 209 209
Loosening of Implant Not Related to Bone-Ingrowth 153 153
Migration or Expulsion of Device 147 147
Material Deformation 138 138
Device Slipped 123 123
Use of Device Problem 116 116
Positioning Failure 116 116
Patient Device Interaction Problem 109 109
Device Dislodged or Dislocated 102 102
Detachment of Device or Device Component 85 85
Patient-Device Incompatibility 74 74
Material Fragmentation 72 72
Defective Device 64 64
Delivered as Unsterile Product 63 63
Entrapment of Device 58 58
Unintended Movement 56 56
Physical Resistance/Sticking 55 55
Corroded 53 53
Manufacturing, Packaging or Shipping Problem 48 48
Osseointegration Problem 46 46
Difficult to Remove 45 45
Loose or Intermittent Connection 43 43
Off-Label Use 41 41
Tear, Rip or Hole in Device Packaging 40 40
Packaging Problem 39 39
Difficult to Insert 37 37
Mechanical Problem 36 36
Inadequacy of Device Shape and/or Size 36 36
Material Integrity Problem 35 35
Malposition of Device 35 35
Improper or Incorrect Procedure or Method 29 29
Fitting Problem 29 29
Unstable 29 29
Crack 28 28
Positioning Problem 28 28
Connection Problem 27 27
Noise, Audible 24 24
Naturally Worn 21 21
Device Contaminated During Manufacture or Shipping 21 21
Loss of or Failure to Bond 19 19
Inaccurate Information 18 18
Unsealed Device Packaging 17 17
Contamination /Decontamination Problem 15 15
Separation Problem 14 14
Failure to Osseointegrate 14 14
Loss of Osseointegration 13 13
Device Markings/Labelling Problem 13 13
Failure to Advance 12 12
Device Appears to Trigger Rejection 12 12
Dull, Blunt 11 11
Incomplete or Inadequate Connection 11 11
Therapeutic or Diagnostic Output Failure 11 11
Difficult to Advance 10 10
Material Separation 10 10
Component Missing 9 9
Mechanical Jam 9 9
Device Damaged by Another Device 9 9
Failure to Align 8 8
Material Discolored 7 7
Failure to Cut 7 7
Biocompatibility 7 7
Material Protrusion/Extrusion 7 7
Output Problem 7 7
Deformation Due to Compressive Stress 6 6
Device Difficult to Maintain 6 6
Device Difficult to Setup or Prepare 6 6
Nonstandard Device 6 6
Unexpected Therapeutic Results 5 5
Defective Component 5 5
Degraded 5 5
Flaked 5 5
Installation-Related Problem 5 5
Blocked Connection 4 4
Device Handling Problem 4 4
Difficult or Delayed Separation 4 4
Contamination 4 4
Difficult or Delayed Positioning 4 4
Material Erosion 3 3
Incorrect Measurement 3 3
Unintended System Motion 3 3
Unraveled Material 3 3
Shipping Damage or Problem 3 3
Material Rupture 3 3
Premature Activation 3 3
Material Split, Cut or Torn 3 3
Scratched Material 3 3
Calibration Problem 3 3
Expiration Date Error 2 2
Separation Failure 2 2
Activation, Positioning or Separation Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Expulsion 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2087 2087
No Clinical Signs, Symptoms or Conditions 1769 1769
Non-union Bone Fracture 1754 1755
Pain 1669 1670
Failure of Implant 1406 1408
Unspecified Infection 1204 1204
Insufficient Information 800 800
Bone Fracture(s) 755 756
Injury 493 493
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 438 438
No Known Impact Or Consequence To Patient 419 419
Impaired Healing 402 402
Loss of Range of Motion 396 396
Discomfort 378 378
No Consequences Or Impact To Patient 347 347
Post Operative Wound Infection 339 339
Necrosis 337 337
Foreign Body In Patient 245 245
Nerve Damage 241 241
Implant Pain 212 212
No Information 195 195
Skin Inflammation/ Irritation 177 177
Malunion of Bone 176 176
Physical Asymmetry 171 171
Arthritis 160 160
Wound Dehiscence 150 150
Hypersensitivity/Allergic reaction 133 133
Swelling/ Edema 128 128
No Patient Involvement 110 110
Unspecified Tissue Injury 109 109
Device Embedded In Tissue or Plaque 104 104
Muscular Rigidity 79 79
Muscle/Tendon Damage 75 75
Swelling 69 69
Osteolysis 66 66
Hematoma 63 63
Deformity/ Disfigurement 62 62
Fall 60 60
Reaction 54 54
Irritation 53 53
Inflammation 52 52
Skin Irritation 51 51
Joint Dislocation 50 50
Hypoesthesia 48 48
Dysphagia/ Odynophagia 48 48
Ossification 41 41
Tissue Damage 41 41
Numbness 40 40
Unspecified Musculoskeletal problem 37 37
Hemorrhage/Bleeding 35 36
Bacterial Infection 34 34
Scar Tissue 32 32
Adhesion(s) 31 31
Osteopenia/ Osteoporosis 31 31
Calcium Deposits/Calcification 29 29
Pneumothorax 24 24
Burning Sensation 24 24
Fluid Discharge 23 23
Ambulation Difficulties 23 23
Metal Related Pathology 23 23
Patient Problem/Medical Problem 21 21
Cerebrospinal Fluid Leakage 21 21
Rash 20 20
Neuropathy 20 20
Perforation 19 19
Sepsis 19 19
Fistula 19 19
Inadequate Osseointegration 19 19
Thrombosis/Thrombus 19 19
Rupture 18 18
Abscess 17 17
Joint Disorder 15 15
Limb Fracture 15 15
Joint Contracture 15 15
Decreased Sensitivity 14 14
Visual Impairment 14 14
Foreign Body Reaction 14 14
Fatigue 13 13
Weakness 13 13
Thrombosis 13 13
Pleural Effusion 13 13
Pneumonia 13 13
Blood Loss 13 13
Limited Mobility Of The Implanted Joint 12 12
Paralysis 12 12
Tingling 12 12
Itching Sensation 12 12
Pulmonary Embolism 12 12
Pocket Erosion 11 11
Skin Infection 11 11
Visual Disturbances 10 10
Edema 10 10
Death 10 10
Eye Injury 10 10
Cyst(s) 9 9
Dyspnea 9 9
Cellulitis 9 9
Local Reaction 9 9
Seroma 8 8
Skin Erosion 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Feb-29-2024
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 Flower Orthopedics Corporation II Oct-06-2021
7 Flower Orthopedics Corporation II Aug-12-2020
8 GRAMERCY EXTREMITY ORTHOPEDICS II Apr-17-2023
9 I.T.S. GmbH II Jun-04-2019
10 K2M, Inc II Apr-12-2021
11 Miami Device Solutions, LLC. II Dec-05-2019
12 Nextremity Solutions II Feb-11-2020
13 Nextremity Solutions II Nov-22-2019
14 Paragon 28, Inc. II Jul-25-2022
15 Smith & Nephew, Inc. II Feb-01-2022
16 Smith & Nephew, Inc. II Dec-10-2021
17 Smith & Nephew, Inc. II Nov-18-2021
18 Smith & Nephew, Inc. II Sep-09-2020
19 Stryker GmbH II Jan-07-2020
20 Synthes (USA) Products LLC II Mar-01-2024
21 Synthes (USA) Products LLC II Aug-17-2020
22 Synthes, Inc. II Jan-29-2020
23 Toby Orthopaedics, Inc. II Dec-04-2019
24 TriMed Inc. II Jan-31-2024
25 TriMed Inc. II Nov-13-2019
26 TriMed Inc. II Oct-10-2019
27 TriMed Inc. II Apr-23-2019
28 Wishbone Medical, Inc. II Jun-04-2021
29 Wright Medical Technology Inc II Dec-17-2021
30 Wright Medical Technology, Inc. II Apr-26-2023
31 Wright Medical Technology, Inc. II Feb-24-2023
32 Wright Medical Technology, Inc. II Mar-15-2022
33 Wright Medical Technology, Inc. II Feb-25-2022
34 Wright Medical Technology, Inc. II Dec-20-2021
35 Wright Medical Technology, Inc. II Nov-25-2019
36 Zimmer Biomet, Inc. II Nov-07-2019
37 Zimmer, Inc. II Jul-28-2023
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