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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 3
AUSTIN MILLER TRAUMA LLC
  SUBSTANTIALLY EQUIVALENT 1
CITIEFFE S.R.L
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
GLW MEDICAL INNOVATION
  SUBSTANTIALLY EQUIVALENT 1
HNM TOTAL RECON, LLC
  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 3
ORTHONOVIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSPIN
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSPIN LTD
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC
  SUBSTANTIALLY EQUIVALENT 1
PEGA MEDICAL 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 3
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S
  SUBSTANTIALLY EQUIVALENT 1
VILEX LLC
  SUBSTANTIALLY EQUIVALENT 1
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 2
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 485 485
2018 597 597
2019 800 800
2020 942 942
2021 963 963
2022 443 444

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1805 1805
Break 725 725
Migration 310 311
Device-Device Incompatibility 309 309
Mechanical Problem 112 112
Fracture 102 102
Unintended Movement 89 89
Insufficient Information 82 82
Material Twisted/Bent 75 75
Material Deformation 62 62
Device Slipped 60 60
Migration or Expulsion of Device 58 58
Appropriate Term/Code Not Available 53 53
Device Operates Differently Than Expected 49 49
Mechanical Jam 45 45
No Apparent Adverse Event 42 42
Manufacturing, Packaging or Shipping Problem 23 23
Crack 23 23
Use of Device Problem 22 22
Loosening of Implant Not Related to Bone-Ingrowth 20 20
Corroded 19 19
Fitting Problem 17 17
Detachment of Device or Device Component 17 17
Loss of Osseointegration 16 16
Loose or Intermittent Connection 16 16
Detachment Of Device Component 15 15
Entrapment of Device 15 15
Contamination /Decontamination Problem 15 15
Defective Device 14 14
Patient Device Interaction Problem 13 13
Physical Resistance/Sticking 13 13
Failure to Align 12 12
Component Falling 12 12
Difficult to Remove 11 11
Improper or Incorrect Procedure or Method 10 10
Material Fragmentation 10 10
Mechanics Altered 10 10
Device Dislodged or Dislocated 9 9
Difficult to Insert 9 9
Bent 8 8
Material Integrity Problem 8 8
Connection Problem 8 8
Naturally Worn 7 7
Failure to Osseointegrate 7 7
Device Inoperable 7 7
Patient-Device Incompatibility 6 6
Nonstandard Device 6 6
Difficult to Advance 6 6
Peeled/Delaminated 5 5
Material Discolored 5 5
Failure To Adhere Or Bond 5 5
Malposition of Device 5 5
Unstable 5 5
Device Difficult to Setup or Prepare 4 4
Material Separation 4 4
Device Damaged Prior to Use 4 4
Degraded 4 4
Difficult or Delayed Positioning 4 4
Device Markings/Labelling Problem 4 4
Device Damaged by Another Device 4 4
Positioning Problem 4 4
Device Difficult to Maintain 4 4
Incomplete or Inadequate Connection 4 4
Failure to Cut 3 3
Device Contaminated During Manufacture or Shipping 3 3
Positioning Failure 3 3
Computer Software Problem 3 3
Disconnection 3 3
Unintended System Motion 3 3
Microbial Contamination of Device 3 3
Component Missing 3 3
Failure to Advance 2 2
Defective Component 2 2
Application Program Problem 2 2
Material Too Rigid or Stiff 2 2
Material Frayed 2 2
Device Operational Issue 2 2
Packaging Problem 2 2
Unclear Information 2 2
Activation Problem 1 1
Difficult or Delayed Separation 1 1
Premature Separation 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Handling Problem 1 1
Material Split, Cut or Torn 1 1
Failure to Eject 1 1
Activation, Positioning or SeparationProblem 1 1
Material Protrusion/Extrusion 1 1
Compatibility Problem 1 1
Incorrect Device Or Component Shipped 1 1
Inflation Problem 1 1
Material Disintegration 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Premature Activation 1 1
Delivered as Unsterile Product 1 1
Use of Incorrect Control Settings 1 1
Loss of or Failure to Bond 1 1
Material Erosion 1 1
Device Expiration Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 1164 1164
No Clinical Signs, Symptoms or Conditions 479 479
Pain 439 439
Non-union Bone Fracture 389 389
Failure of Implant 372 372
Unspecified Infection 362 362
Bone Fracture(s) 339 339
No Consequences Or Impact To Patient 246 246
No Known Impact Or Consequence To Patient 242 242
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 204 204
Injury 153 153
Post Operative Wound Infection 136 136
Necrosis 134 134
Impaired Healing 128 128
No Patient Involvement 115 115
Physical Asymmetry 69 69
Insufficient Information 53 54
Discomfort 48 48
Loss of Range of Motion 45 45
Foreign Body In Patient 34 34
Malunion of Bone 34 34
No Information 32 32
Joint Dislocation 27 27
Unspecified Tissue Injury 25 25
Nerve Damage 24 24
Reaction 20 20
Hypersensitivity/Allergic reaction 20 20
Device Embedded In Tissue or Plaque 19 19
Not Applicable 19 19
Deformity/ Disfigurement 17 17
Wound Dehiscence 16 16
Blood Loss 14 14
Sepsis 13 13
Arthritis 13 13
Hematoma 12 12
Fluid Discharge 11 11
Death 10 10
Fall 9 9
Bacterial Infection 9 9
Skin Erosion 9 9
Limb Fracture 9 9
Patient Problem/Medical Problem 8 8
Inflammation 8 8
Discharge 7 7
Thrombosis 7 7
Ambulation Difficulties 7 7
Swelling 6 6
Paralysis 6 6
Hemorrhage/Bleeding 6 6
Fistula 6 6
Irritation 5 5
Pulmonary Embolism 5 5
Skin Inflammation/ Irritation 5 5
Swelling/ Edema 5 5
Implant Pain 4 4
Cellulitis 4 4
Cyst(s) 4 4
Tissue Damage 4 4
Weakness 3 3
Perforation 3 3
Skin Irritation 3 3
Hypoesthesia 3 3
Spinal Cord Injury 3 3
Osteolysis 3 3
Purulent Discharge 3 3
Limited Mobility Of The Implanted Joint 3 3
Metal Related Pathology 2 2
Abscess 2 2
Erosion 2 2
Fever 2 2
Foreign Body Sensation in Eye 2 2
Sedation 2 2
Hip Fracture 2 2
Numbness 2 2
Burning Sensation 2 2
Tingling 2 2
Ulcer 2 2
Visual Disturbances 1 1
Seroma 1 1
Paresis 1 1
Bronchopneumonia 1 1
Disability 1 1
Internal Organ Perforation 1 1
Itching Sensation 1 1
Damage to Ligament(s) 1 1
Muscular Rigidity 1 1
Myocardial Infarction 1 1
Calcium Deposits/Calcification 1 1
Cardiac Arrest 1 1
Anemia 1 1
Ossification 1 1
Embolism 1 1
Erythema 1 1
Eye Injury 1 1
Congenital Defect/Deformity 1 1
Fatigue 1 1
Osteomyelitis 1 1
Unequal Limb Length 1 1
Neuralgia 1 1
Embolism/Embolus 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 Orthofix Srl II Dec-27-2017
9 Stryker GmbH II Oct-29-2018
10 Stryker GmbH II Sep-22-2018
11 Stryker GmbH II Apr-26-2018
12 Stryker Howmedica Osteonics Corp. II May-25-2017
13 Zimmer Biomet, Inc. II Nov-22-2019
14 Zimmer Biomet, Inc. II Nov-07-2019
15 Zimmer Biomet, Inc. II Jun-15-2017
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