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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
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 1
AAP IMPLANTATE AG
  SUBSTANTIALLY EQUIVALENT 5
ACUMED LLC
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
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 12
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 4
AVANTI ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICOFIXATION
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 3
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BONEBRIDGE AG
  SUBSTANTIALLY EQUIVALENT 2
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 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
EXREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
EXSOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 2
FIELD ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
FIXIER, S.A. DE C.V.
  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 4
GLW MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
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
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
HOSPITAL EQUIPMENT MANUFACTURING COMPANY
  SUBSTANTIALLY EQUIVALENT 1
I.T.S. GMBH
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 11
INDUSTRIAS MEDICAS SAMPEDRO S.A.S
  SUBSTANTIALLY EQUIVALENT 1
INTAI TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  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 1
KLS MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 2
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 10
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIAMI DEVICE SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
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 7
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 4
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 3
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 4
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 CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIG MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 9
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 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 4
TDM CO. LTD.
  SUBSTANTIALLY EQUIVALENT 3
TECHFIT DIGITAL SURGERY INC.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 2
TREACE MEDICAL CONCEPTS INC.
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
TRIDENT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRUEMED GROUP LLC
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
VILEX LLC
  SUBSTANTIALLY EQUIVALENT 3
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 2663 2663
2019 3356 3356
2020 2791 2791
2021 2448 2448
2022 1720 1723
2023 607 607

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6143 6145
Break 2336 2338
Fracture 1021 1023
Device-Device Incompatibility 579 579
Migration 495 495
Appropriate Term/Code Not Available 294 294
Insufficient Information 251 251
Material Twisted/Bent 201 201
No Apparent Adverse Event 193 193
Migration or Expulsion of Device 191 191
Device Slipped 143 143
Material Deformation 120 120
Device Dislodged or Dislocated 109 109
Patient-Device Incompatibility 109 109
Use of Device Problem 108 108
Loosening of Implant Not Related to Bone-Ingrowth 104 104
Positioning Failure 95 95
Physical Resistance/Sticking 93 93
Detachment of Device or Device Component 90 90
Manufacturing, Packaging or Shipping Problem 87 87
Packaging Problem 84 84
Corroded 84 84
Mechanical Problem 65 65
Loose or Intermittent Connection 59 59
Material Fragmentation 58 58
Delivered as Unsterile Product 58 58
Device Operates Differently Than Expected 58 58
Patient Device Interaction Problem 57 57
Entrapment of Device 56 56
Difficult to Remove 51 51
Osseointegration Problem 48 48
Malposition of Device 47 47
Defective Device 46 46
Inadequacy of Device Shape and/or Size 45 45
Difficult to Insert 44 44
Unintended Movement 42 42
Device Contaminated During Manufacture or Shipping 40 40
Positioning Problem 36 36
Improper or Incorrect Procedure or Method 36 36
Separation Failure 35 35
Connection Problem 34 34
Material Discolored 34 34
Unstable 31 31
Material Integrity Problem 31 31
Crack 30 30
Tear, Rip or Hole in Device Packaging 29 29
Device Markings/Labelling Problem 28 28
Device Inoperable 28 28
Off-Label Use 28 28
Dull, Blunt 27 27
Failure to Osseointegrate 24 24
Fitting Problem 22 22
Loss of or Failure to Bond 22 22
Unsealed Device Packaging 20 20
Failure to Align 20 20
Sharp Edges 19 19
Noise, Audible 18 18
Inaccurate Information 18 18
Naturally Worn 18 18
Mechanics Altered 16 16
Component Missing 16 16
Contamination /Decontamination Problem 16 16
Bent 16 16
Device Contamination with Chemical or Other Material 15 15
Mechanical Jam 13 13
Loss of Osseointegration 13 13
Device Appears to Trigger Rejection 13 13
Separation Problem 13 13
Incomplete or Inadequate Connection 11 11
Material Protrusion/Extrusion 10 10
Device Damaged by Another Device 10 10
Therapeutic or Diagnostic Output Failure 10 10
Device Difficult to Maintain 9 9
Device Packaging Compromised 9 9
Nonstandard Device 9 9
Material Separation 9 9
Failure To Adhere Or Bond 9 9
Fail-Safe Design Failure 8 8
Flaked 8 8
Biocompatibility 8 8
Deformation Due to Compressive Stress 7 7
Output Problem 7 7
Pressure Problem 5 5
Failure to Advance 5 5
Defective Component 5 5
Degraded 5 5
Material Rupture 5 5
Unexpected Therapeutic Results 5 5
Peeled/Delaminated 5 5
Difficult To Position 4 4
Device Difficult to Setup or Prepare 4 4
Metal Shedding Debris 4 4
Difficult or Delayed Positioning 4 4
Contamination 4 4
Detachment Of Device Component 4 4
Material Erosion 4 4
Blocked Connection 4 4
Device Handling Problem 4 4
Difficult to Advance 4 4
Activation, Positioning or Separation Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2610 2610
Pain 1703 1703
Non-union Bone Fracture 1607 1608
Failure of Implant 1293 1295
No Clinical Signs, Symptoms or Conditions 1285 1285
Unspecified Infection 1217 1217
Bone Fracture(s) 885 886
No Known Impact Or Consequence To Patient 704 704
Injury 547 547
No Consequences Or Impact To Patient 542 542
Impaired Healing 532 532
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 434 434
No Information 396 396
Loss of Range of Motion 394 394
Discomfort 360 360
Post Operative Wound Infection 308 308
Insufficient Information 302 302
Necrosis 300 300
No Patient Involvement 254 254
Nerve Damage 236 236
Foreign Body In Patient 201 201
Physical Asymmetry 149 149
Malunion of Bone 145 145
Arthritis 140 140
Hypersensitivity/Allergic reaction 133 133
Swelling 119 119
Device Embedded In Tissue or Plaque 118 118
Implant Pain 117 117
Wound Dehiscence 114 114
Skin Inflammation/ Irritation 90 90
Swelling/ Edema 84 84
Reaction 83 83
Osteolysis 77 77
Unspecified Tissue Injury 76 76
Irritation 76 76
Skin Irritation 61 61
Hematoma 59 59
Fall 55 55
Tissue Damage 52 52
Dysphagia/ Odynophagia 51 51
Hypoesthesia 51 51
Inflammation 49 49
Not Applicable 47 47
Joint Dislocation 46 46
Deformity/ Disfigurement 41 41
Hemorrhage/Bleeding 41 42
Ossification 38 38
Muscular Rigidity 38 38
Patient Problem/Medical Problem 36 36
Calcium Deposits/Calcification 35 35
Limited Mobility Of The Implanted Joint 29 29
Muscle/Tendon Damage 29 29
Adhesion(s) 28 28
Rupture 27 27
Pneumothorax 25 25
Bacterial Infection 25 25
Cellulitis 25 25
Rash 24 24
Numbness 24 24
Cerebrospinal Fluid Leakage 23 23
Fistula 22 22
Laceration(s) 22 22
Inadequate Osseointegration 22 22
Ambulation Difficulties 21 21
Metal Related Pathology 21 21
Abscess 19 19
Neuropathy 18 18
Sepsis 18 18
Erosion 17 17
Death 17 17
Scar Tissue 16 16
Perforation of Vessels 16 16
Visual Impairment 15 15
Foreign Body Reaction 15 15
Erythema 15 15
Joint Disorder 15 15
Blood Loss 14 14
Chest Pain 14 14
Thrombosis 14 14
Weakness 14 14
Pocket Erosion 14 14
Paralysis 13 13
Skin Erosion 13 13
Eye Injury 13 13
Osteopenia/ Osteoporosis 13 13
Limb Fracture 13 13
Fatigue 12 12
Burning Sensation 12 12
Tingling 12 12
Itching Sensation 12 12
Perforation 12 12
Pneumonia 11 11
Skin Infection 11 11
Unspecified Musculoskeletal problem 10 10
Local Reaction 10 10
Skin Discoloration 10 10
Visual Disturbances 10 10
Edema 10 10
Purulent Discharge 10 10
Cyst(s) 9 9

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Apr-09-2021
2 Arthrex, Inc. II Jul-29-2020
3 Biomet II Jun-09-2020
4 Biomet, Inc. II Jan-21-2021
5 Epic Extremity, LLC II May-15-2018
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 NewDeal SA II Jul-16-2018
13 Nextremity Solutions II Feb-11-2020
14 Nextremity Solutions II Nov-22-2019
15 Orthofix, Inc II Jun-07-2018
16 Paragon 28, Inc. II Jul-25-2022
17 Smith & Nephew, Inc. II Feb-01-2022
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 Stryker GmbH II Jan-07-2020
24 Synthes (USA) Products LLC II Aug-17-2020
25 Synthes, Inc. II Jan-29-2020
26 Toby Orthopaedics, Inc. II Dec-04-2019
27 TriMed Inc. II Nov-13-2019
28 TriMed Inc. II Oct-10-2019
29 TriMed Inc. II Apr-23-2019
30 TriMed Inc. II Aug-18-2018
31 Wishbone Medical, Inc. II Jun-04-2021
32 Wright Medical Technology Inc II Dec-17-2021
33 Wright Medical Technology, Inc. II Apr-26-2023
34 Wright Medical Technology, Inc. II Feb-24-2023
35 Wright Medical Technology, Inc. II Mar-15-2022
36 Wright Medical Technology, Inc. II Feb-25-2022
37 Wright Medical Technology, Inc. II Dec-20-2021
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
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