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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 2
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 8
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
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 8
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, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 7
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 2
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 2662 2662
2019 3356 3356
2020 2791 2791
2021 2448 2448
2022 1720 1723
2023 204 204

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5950 5952
Break 2280 2282
Fracture 991 993
Device-Device Incompatibility 567 567
Migration 466 466
Appropriate Term/Code Not Available 293 293
Insufficient Information 230 230
Material Twisted/Bent 191 191
No Apparent Adverse Event 188 188
Migration or Expulsion of Device 186 186
Device Slipped 139 139
Material Deformation 119 119
Device Dislodged or Dislocated 109 109
Patient-Device Incompatibility 109 109
Use of Device Problem 106 106
Positioning Failure 93 93
Physical Resistance/Sticking 93 93
Loosening of Implant Not Related to Bone-Ingrowth 89 89
Detachment of Device or Device Component 88 88
Manufacturing, Packaging or Shipping Problem 85 85
Packaging Problem 84 84
Corroded 84 84
Mechanical Problem 63 63
Loose or Intermittent Connection 59 59
Material Fragmentation 58 58
Device Operates Differently Than Expected 58 58
Patient Device Interaction Problem 55 55
Entrapment of Device 54 54
Delivered as Unsterile Product 51 51
Difficult to Remove 50 50
Osseointegration Problem 47 47
Malposition of Device 45 45
Inadequacy of Device Shape and/or Size 45 45
Difficult to Insert 44 44
Defective Device 43 43
Unintended Movement 41 41
Device Contaminated During Manufacture or Shipping 40 40
Positioning Problem 36 36
Separation Failure 35 35
Improper or Incorrect Procedure or Method 35 35
Connection Problem 34 34
Material Discolored 34 34
Unstable 31 31
Crack 30 30
Material Integrity Problem 30 30
Device Markings/Labelling Problem 28 28
Device Inoperable 28 28
Off-Label Use 27 27
Tear, Rip or Hole in Device Packaging 26 26
Failure to Osseointegrate 24 24
Fitting Problem 22 22
Failure to Align 20 20
Unsealed Device Packaging 19 19
Sharp Edges 19 19
Noise, Audible 18 18
Dull, Blunt 18 18
Naturally Worn 18 18
Inaccurate Information 17 17
Component Missing 16 16
Bent 16 16
Contamination /Decontamination Problem 15 15
Mechanics Altered 15 15
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
Therapeutic or Diagnostic Output Failure 10 10
Device Difficult to Maintain 9 9
Device Damaged by Another Device 9 9
Device Packaging Compromised 9 9
Material Separation 9 9
Failure To Adhere Or Bond 9 9
Loss of or Failure to Bond 8 8
Fail-Safe Design Failure 8 8
Flaked 8 8
Nonstandard Device 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
Peeled/Delaminated 5 5
Material Rupture 5 5
Unexpected Therapeutic Results 5 5
Degraded 5 5
Difficult or Delayed Positioning 4 4
Contamination 4 4
Detachment Of Device Component 4 4
Material Erosion 4 4
Metal Shedding Debris 4 4
Difficult To Position 4 4
Blocked Connection 4 4
Device Handling Problem 4 4
Difficult to Advance 4 4
Activation, Positioning or Separation Problem 4 4
Difficult or Delayed Separation 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2610 2610
Pain 1614 1614
Non-union Bone Fracture 1539 1540
No Clinical Signs, Symptoms or Conditions 1219 1219
Failure of Implant 1207 1209
Unspecified Infection 1183 1183
Bone Fracture(s) 874 875
No Known Impact Or Consequence To Patient 704 704
Injury 547 547
No Consequences Or Impact To Patient 542 542
Impaired Healing 524 524
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 432 432
No Information 396 396
Loss of Range of Motion 361 361
Discomfort 326 326
Post Operative Wound Infection 301 301
Necrosis 281 281
No Patient Involvement 254 254
Insufficient Information 253 253
Nerve Damage 226 226
Foreign Body In Patient 194 194
Physical Asymmetry 146 146
Malunion of Bone 142 142
Arthritis 138 138
Hypersensitivity/Allergic reaction 130 130
Swelling 119 119
Device Embedded In Tissue or Plaque 117 117
Implant Pain 115 115
Wound Dehiscence 100 100
Reaction 83 83
Skin Inflammation/ Irritation 76 76
Irritation 76 76
Osteolysis 74 74
Swelling/ Edema 71 71
Unspecified Tissue Injury 69 69
Skin Irritation 61 61
Hematoma 59 59
Tissue Damage 52 52
Fall 51 51
Hypoesthesia 51 51
Inflammation 49 49
Dysphagia/ Odynophagia 47 47
Not Applicable 47 47
Joint Dislocation 45 45
Hemorrhage/Bleeding 41 42
Deformity/ Disfigurement 39 39
Muscular Rigidity 37 37
Patient Problem/Medical Problem 36 36
Calcium Deposits/Calcification 35 35
Ossification 31 31
Limited Mobility Of The Implanted Joint 29 29
Muscle/Tendon Damage 28 28
Adhesion(s) 28 28
Rupture 26 26
Pneumothorax 25 25
Cellulitis 25 25
Bacterial Infection 24 24
Cerebrospinal Fluid Leakage 23 23
Fistula 22 22
Laceration(s) 22 22
Numbness 22 22
Inadequate Osseointegration 21 21
Metal Related Pathology 21 21
Rash 20 20
Sepsis 18 18
Neuropathy 18 18
Abscess 18 18
Ambulation Difficulties 18 18
Erosion 17 17
Death 17 17
Foreign Body Reaction 15 15
Erythema 15 15
Visual Impairment 15 15
Joint Disorder 15 15
Blood Loss 14 14
Thrombosis 14 14
Weakness 14 14
Scar Tissue 14 14
Pocket Erosion 14 14
Paralysis 13 13
Skin Erosion 13 13
Eye Injury 13 13
Chest Pain 13 13
Osteopenia/ Osteoporosis 13 13
Limb Fracture 13 13
Fatigue 12 12
Burning Sensation 12 12
Tingling 12 12
Itching Sensation 12 12
Skin Infection 11 11
Local Reaction 10 10
Perforation 10 10
Visual Disturbances 10 10
Skin Discoloration 10 10
Edema 10 10
Purulent Discharge 10 10
Fever 9 9
Complaint, Ill-Defined 9 9
Pneumonia 9 9
Ulcer 8 8

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 I.T.S. GmbH II Jun-04-2019
9 K2M, Inc II Apr-12-2021
10 Miami Device Solutions, LLC. II Dec-05-2019
11 NewDeal SA II Jul-16-2018
12 Nextremity Solutions II Feb-11-2020
13 Nextremity Solutions II Nov-22-2019
14 Orthofix, Inc II Jun-07-2018
15 Paragon 28, Inc. II Jul-25-2022
16 Smith & Nephew, Inc. II Feb-01-2022
17 Smith & Nephew, Inc. II Dec-10-2021
18 Smith & Nephew, Inc. II Nov-18-2021
19 Smith & Nephew, Inc. II Sep-09-2020
20 Smith & Nephew, Inc. II Jan-24-2018
21 Smith & Nephew, Inc. II Jan-19-2018
22 Stryker GmbH II Jan-07-2020
23 Synthes (USA) Products LLC II Aug-17-2020
24 Synthes, Inc. II Jan-29-2020
25 Toby Orthopaedics, Inc. II Dec-04-2019
26 TriMed Inc. II Nov-13-2019
27 TriMed Inc. II Oct-10-2019
28 TriMed Inc. II Apr-23-2019
29 TriMed Inc. II Aug-18-2018
30 Wishbone Medical, Inc. II Jun-04-2021
31 Wright Medical Technology Inc II Dec-17-2021
32 Wright Medical Technology, Inc. II Feb-24-2023
33 Wright Medical Technology, Inc. II Mar-15-2022
34 Wright Medical Technology, Inc. II Feb-25-2022
35 Wright Medical Technology, Inc. II Dec-20-2021
36 Wright Medical Technology, Inc. II Nov-25-2019
37 Zimmer Biomet, Inc. II Nov-07-2019
38 Zimmer Biomet, Inc. II Aug-31-2018
39 Zimmer Biomet, Inc. II Apr-03-2018
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