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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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
ARTHREX INC
  SUBSTANTIALLY EQUIVALENT 1
AUSTIN MILLER TRAUMA LLC
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
GLW MEDICAL INNOVATION
  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
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 3
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VILEX LLC
  SUBSTANTIALLY EQUIVALENT 1
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 2
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 800 800
2020 942 942
2021 961 961
2022 627 628
2023 551 551
2024 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1683 1683
Break 702 702
Migration 417 418
Device-Device Incompatibility 386 386
Fracture 139 139
Material Twisted/Bent 84 84
Mechanical Problem 62 62
Material Deformation 55 55
Insufficient Information 53 53
Device Slipped 52 52
No Apparent Adverse Event 50 50
Migration or Expulsion of Device 48 48
Mechanical Jam 42 42
Appropriate Term/Code Not Available 41 41
Use of Device Problem 33 33
Manufacturing, Packaging or Shipping Problem 24 24
Defective Device 22 22
Crack 22 22
Loosening of Implant Not Related to Bone-Ingrowth 22 22
Entrapment of Device 20 20
Corroded 19 19
Detachment of Device or Device Component 19 19
Loss of Osseointegration 16 16
Physical Resistance/Sticking 14 14
Material Integrity Problem 12 12
Difficult to Advance 11 11
Unintended Movement 11 11
Mechanics Altered 10 10
Improper or Incorrect Procedure or Method 10 10
Device Contaminated During Manufacture or Shipping 9 9
Connection Problem 8 8
Naturally Worn 7 7
Unintended System Motion 7 7
Device Dislodged or Dislocated 6 6
Failure to Osseointegrate 6 6
Failure to Cut 5 5
Loose or Intermittent Connection 5 5
Device Difficult to Setup or Prepare 5 5
Off-Label Use 5 5
Material Discolored 5 5
Material Fragmentation 5 5
Degraded 4 4
Difficult or Delayed Positioning 4 4
Positioning Failure 4 4
Difficult to Remove 4 4
Patient-Device Incompatibility 4 4
Incomplete or Inadequate Connection 4 4
Patient Device Interaction Problem 4 4
Positioning Problem 3 3
Failure to Align 3 3
Device Damaged Prior to Use 3 3
Component Missing 3 3
Device Markings/Labelling Problem 3 3
Device Damaged by Another Device 3 3
Unstable 3 3
Material Separation 3 3
Difficult to Insert 3 3
Disconnection 3 3
Material Frayed 2 2
Fitting Problem 2 2
Malposition of Device 2 2
Device Difficult to Maintain 2 2
Unclear Information 2 2
Device Handling Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Packaging Problem 1 1
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
Expiration Date Error 1 1
Application Program Problem 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Chemical Problem 1 1
Contamination /Decontamination Problem 1 1
Solder Joint Fracture 1 1
Dull, Blunt 1 1
Defective Component 1 1
Activation, Positioning or Separation Problem 1 1
Difficult to Open or Close 1 1
Material Protrusion/Extrusion 1 1
Inflation Problem 1 1
Unintended Ejection 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
Misassembled 1 1
Nonstandard Device 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Too Rigid or Stiff 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 771 771
No Clinical Signs, Symptoms or Conditions 723 723
Non-union Bone Fracture 412 412
Pain 394 394
Failure of Implant 348 348
Bone Fracture(s) 334 334
Unspecified Infection 240 240
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 213 213
Necrosis 206 206
No Consequences Or Impact To Patient 164 164
Insufficient Information 162 163
Injury 146 146
Post Operative Wound Infection 143 143
Physical Asymmetry 107 107
No Patient Involvement 85 85
No Known Impact Or Consequence To Patient 80 80
Impaired Healing 60 60
Loss of Range of Motion 48 48
Malunion of Bone 43 43
Fall 40 40
Unspecified Tissue Injury 39 39
Discomfort 37 37
Foreign Body In Patient 30 30
Deformity/ Disfigurement 29 29
Hypersensitivity/Allergic reaction 27 27
Limb Fracture 26 26
Joint Dislocation 25 25
Nerve Damage 23 23
Hematoma 20 20
Swelling/ Edema 20 20
Wound Dehiscence 16 16
Arthritis 11 11
Reaction 11 11
Sepsis 11 11
Fluid Discharge 11 11
No Information 11 11
Thrombosis/Thrombus 10 10
Blood Loss 10 10
Skin Erosion 9 9
Inflammation 9 9
Foreign Body Embolism 9 9
Metal Related Pathology 8 8
Device Embedded In Tissue or Plaque 8 8
Bacterial Infection 8 8
Death 7 7
Hemorrhage/Bleeding 7 7
Ambulation Difficulties 7 7
Implant Pain 7 7
Skin Inflammation/ Irritation 6 6
Patient Problem/Medical Problem 6 6
Fistula 6 6
Perforation 5 5
Pulmonary Embolism 5 5
Thrombosis 5 5
Not Applicable 5 5
Cellulitis 4 4
Cyst(s) 4 4
Purulent Discharge 3 3
Weakness 3 3
Hypoesthesia 3 3
Ulcer 3 3
Spinal Cord Injury 3 3
Numbness 3 3
Osteolysis 3 3
Irritability 2 2
Swelling 2 2
Burning Sensation 2 2
Tingling 2 2
Tissue Damage 2 2
Stroke/CVA 2 2
Abscess 2 2
Anemia 2 2
Erosion 2 2
Fever 2 2
Foreign Body Sensation in Eye 2 2
Paralysis 2 2
Inadequate Osseointegration 2 2
Limited Mobility Of The Implanted Joint 2 2
Tissue Breakdown 1 1
Thromboembolism 1 1
Heart Failure/Congestive Heart Failure 1 1
Unspecified Heart Problem 1 1
Subluxation 1 1
Joint Contracture 1 1
Neuralgia 1 1
Embolism/Embolus 1 1
Drug Resistant Bacterial Infection 1 1
Decreased Appetite 1 1
Unequal Limb Length 1 1
Unspecified Musculoskeletal problem 1 1
Internal Organ Perforation 1 1
Muscular Rigidity 1 1
Myocardial Infarction 1 1
Calcium Deposits/Calcification 1 1
Ossification 1 1
Congenital Defect/Deformity 1 1
Fatigue 1 1
Embolism 1 1
Erythema 1 1
Skin Irritation 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 Jun-09-2023
4 New Standard Device Inc II Aug-29-2022
5 New Standard Device Inc II Jun-03-2022
6 OrthoPediatrics Corp II Sep-06-2022
7 Orthofix Srl II Nov-14-2019
8 Stryker GmbH II Mar-01-2023
9 Wishbone Medical, Inc. II Feb-07-2023
10 Zimmer Biomet, Inc. II Nov-22-2019
11 Zimmer Biomet, Inc. II Nov-07-2019
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