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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device appliance, fixation, nail/blade/plate combination, multiple component
Product CodeKTT
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
AIKE (SHANGHAI) MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARROWHEAD DE, LLC
  SUBSTANTIALLY EQUIVALENT 2
AUSTIN MILLER TRAUMA LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
GLW MEDICAL INNOVATION
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
NEW STANDARD DEVICE DBA METALOGIX
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHONOVIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOSPIN
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSPIN LTD
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC
  SUBSTANTIALLY EQUIVALENT 1
S H PITKAR ORTHOTOOLS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
S H PITKAR ORTHOTOOLS PVT LTD.
  SUBSTANTIALLY EQUIVALENT 2
SEQUEL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
VILEX LLC
  SUBSTANTIALLY EQUIVALENT 1
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 2
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 597 597
2019 800 800
2020 942 942
2021 963 963
2022 642 643
2023 187 187

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1734 1734
Break 727 727
Device-Device Incompatibility 363 363
Migration 348 349
Fracture 111 111
Mechanical Problem 89 89
Material Twisted/Bent 81 81
Insufficient Information 77 77
Material Deformation 62 62
Unintended Movement 62 62
Device Slipped 61 61
Migration or Expulsion of Device 52 52
No Apparent Adverse Event 49 49
Mechanical Jam 46 46
Appropriate Term/Code Not Available 44 44
Use of Device Problem 34 34
Device Operates Differently Than Expected 30 30
Crack 23 23
Manufacturing, Packaging or Shipping Problem 23 23
Loosening of Implant Not Related to Bone-Ingrowth 22 22
Detachment of Device or Device Component 21 21
Defective Device 19 19
Corroded 19 19
Loss of Osseointegration 16 16
Contamination /Decontamination Problem 15 15
Entrapment of Device 15 15
Physical Resistance/Sticking 14 14
Patient Device Interaction Problem 13 13
Mechanics Altered 11 11
Material Integrity Problem 10 10
Loose or Intermittent Connection 10 10
Difficult to Remove 9 9
Improper or Incorrect Procedure or Method 8 8
Connection Problem 8 8
Difficult to Advance 8 8
Failure to Osseointegrate 7 7
Material Fragmentation 7 7
Naturally Worn 7 7
Device Dislodged or Dislocated 7 7
Device Inoperable 6 6
Patient-Device Incompatibility 6 6
Failure to Cut 5 5
Failure to Align 5 5
Material Separation 5 5
Difficult to Insert 5 5
Material Discolored 5 5
Degraded 4 4
Difficult or Delayed Positioning 4 4
Positioning Failure 4 4
Detachment Of Device Component 4 4
Component Falling 4 4
Device Difficult to Setup or Prepare 4 4
Fitting Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4
Device Difficult to Maintain 4 4
Incomplete or Inadequate Connection 4 4
Positioning Problem 3 3
Device Damaged Prior to Use 3 3
Unstable 3 3
Microbial Contamination of Device 3 3
Component Missing 3 3
Device Damaged by Another Device 3 3
Device Markings/Labelling Problem 3 3
Malposition of Device 3 3
Unintended System Motion 3 3
Disconnection 3 3
Failure To Adhere Or Bond 3 3
Bent 3 3
Material Frayed 2 2
Application Program Problem 2 2
Device Operational Issue 2 2
Defective Component 2 2
Unclear Information 2 2
Material Split, Cut or Torn 1 1
Failure to Eject 1 1
Activation Problem 1 1
Difficult or Delayed Separation 1 1
Premature Separation 1 1
Device Handling Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Protrusion/Extrusion 1 1
Packaging Problem 1 1
Compatibility Problem 1 1
Solder Joint Fracture 1 1
Dull, Blunt 1 1
Expiration Date Error 1 1
Separation Failure 1 1
Difficult to Open or Close 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Chemical Problem 1 1
Folded 1 1
Activation, Positioning or Separation Problem 1 1
Inflation Problem 1 1
Loss of or Failure to Bond 1 1
Use of Incorrect Control/Treatment Settings 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Nonstandard Device 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 968 968
No Clinical Signs, Symptoms or Conditions 615 615
Pain 424 424
Non-union Bone Fracture 396 396
Failure of Implant 359 359
Bone Fracture(s) 345 345
Unspecified Infection 274 274
No Consequences Or Impact To Patient 221 221
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 215 215
No Known Impact Or Consequence To Patient 165 165
Necrosis 155 155
Injury 151 151
Post Operative Wound Infection 139 139
No Patient Involvement 112 112
Impaired Healing 89 89
Insufficient Information 85 86
Physical Asymmetry 74 74
Loss of Range of Motion 49 49
Discomfort 43 43
Malunion of Bone 41 41
Unspecified Tissue Injury 33 33
Foreign Body In Patient 32 32
Hypersensitivity/Allergic reaction 27 27
Joint Dislocation 25 25
No Information 24 24
Nerve Damage 23 23
Deformity/ Disfigurement 22 22
Not Applicable 18 18
Wound Dehiscence 16 16
Swelling/ Edema 15 15
Blood Loss 14 14
Hematoma 14 14
Reaction 13 13
Device Embedded In Tissue or Plaque 13 13
Limb Fracture 12 12
Sepsis 12 12
Fluid Discharge 11 11
Arthritis 10 10
Fall 10 10
Bacterial Infection 9 9
Skin Erosion 9 9
Paralysis 8 8
Inflammation 8 8
Patient Problem/Medical Problem 8 8
Metal Related Pathology 8 8
Thrombosis/Thrombus 8 8
Death 7 7
Ambulation Difficulties 7 7
Swelling 6 6
Fistula 6 6
Hemorrhage/Bleeding 6 6
Implant Pain 6 6
Skin Inflammation/ Irritation 5 5
Pulmonary Embolism 5 5
Thrombosis 5 5
Tissue Damage 4 4
Cellulitis 4 4
Perforation 4 4
Cyst(s) 4 4
Purulent Discharge 3 3
Weakness 3 3
Hypoesthesia 3 3
Limited Mobility Of The Implanted Joint 3 3
Numbness 3 3
Osteolysis 3 3
Spinal Cord Injury 3 3
Inadequate Osseointegration 2 2
Ulcer 2 2
Burning Sensation 2 2
Tingling 2 2
Stroke/CVA 2 2
Abscess 2 2
Erosion 2 2
Fever 2 2
Foreign Body Sensation in Eye 2 2
Irritation 2 2
Muscular Rigidity 1 1
Myocardial Infarction 1 1
Seroma 1 1
Internal Organ Perforation 1 1
Calcium Deposits/Calcification 1 1
Anemia 1 1
Ossification 1 1
Congenital Defect/Deformity 1 1
Fatigue 1 1
Embolism 1 1
Erythema 1 1
Skin Irritation 1 1
Discharge 1 1
Hip Fracture 1 1
Disability 1 1
Thromboembolism 1 1
Tissue Breakdown 1 1
Needle Stick/Puncture 1 1
Bronchopneumonia 1 1
Respiratory Tract Infection 1 1
Drug Resistant Bacterial Infection 1 1
Subluxation 1 1
Joint Contracture 1 1
Decreased Appetite 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Feb-16-2022
2 Medicalplastic S.R.L. II Nov-17-2021
3 New Standard Device Inc II Aug-29-2022
4 New Standard Device Inc II Jun-03-2022
5 OrthoPediatrics Corp II Sep-06-2022
6 Orthofix Srl II Nov-14-2019
7 Orthofix Srl II Jun-05-2018
8 Stryker GmbH II Mar-01-2023
9 Stryker GmbH II Oct-29-2018
10 Stryker GmbH II Sep-22-2018
11 Stryker GmbH II Apr-26-2018
12 Wishbone Medical, Inc. II Feb-07-2023
13 Zimmer Biomet, Inc. II Nov-22-2019
14 Zimmer Biomet, Inc. II Nov-07-2019
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