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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
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 3
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 1
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 941 941
2021 958 958

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1630 1630
Break 613 613
Device-Device Incompatibility 268 268
Migration 252 252
Mechanical Problem 112 112
Unintended Movement 89 89
Fracture 86 86
Insufficient Information 81 81
Material Twisted/Bent 68 68
Migration or Expulsion of Device 58 58
Material Deformation 57 57
Device Slipped 56 56
Device Operates Differently Than Expected 49 49
Appropriate Term/Code Not Available 44 44
Mechanical Jam 42 42
No Apparent Adverse Event 35 35
Manufacturing, Packaging or Shipping Problem 23 23
Use of Device Problem 21 21
Crack 21 21
Corroded 19 19
Loosening of Implant Not Related to Bone-Ingrowth 18 18
Fitting Problem 17 17
Loss of Osseointegration 16 16
Loose or Intermittent Connection 16 16
Detachment Of Device Component 15 15
Contamination /Decontamination Problem 15 15
Defective Device 14 14
Detachment of Device or Device Component 13 13
Patient Device Interaction Problem 13 13
Physical Resistance/Sticking 13 13
Failure to Align 12 12
Component Falling 12 12
Difficult to Remove 10 10
Material Fragmentation 10 10
Difficult to Insert 9 9
Entrapment of Device 9 9
Improper or Incorrect Procedure or Method 9 9
Mechanics Altered 9 9
Device Dislodged or Dislocated 9 9
Bent 8 8
Failure to Osseointegrate 7 7
Device Inoperable 7 7
Connection Problem 7 7
Material Integrity Problem 7 7
Patient-Device Incompatibility 6 6
Nonstandard Device 6 6
Material Discolored 5 5
Peeled/Delaminated 5 5
Failure To Adhere Or Bond 5 5
Unstable 5 5
Difficult to Advance 5 5
Naturally Worn 5 5
Device Damaged by Another Device 4 4
Incomplete or Inadequate Connection 4 4
Device Difficult to Maintain 4 4
Material Separation 4 4
Device Markings/Labelling Problem 4 4
Difficult or Delayed Positioning 4 4
Device Difficult to Setup or Prepare 4 4
Disconnection 3 3
Positioning Failure 3 3
Computer Software Problem 3 3
Malposition of Device 3 3
Device Damaged Prior to Use 3 3
Microbial Contamination of Device 3 3
Component Missing 3 3
Positioning Problem 3 3
Failure to Cut 3 3
Device Operational Issue 2 2
Packaging Problem 2 2
Defective Component 2 2
Failure to Advance 2 2
Application Program Problem 2 2
Degraded 2 2
Material Frayed 2 2
Material Too Rigid or Stiff 2 2
Material Rupture 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Premature Activation 1 1
Material Disintegration 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Material Erosion 1 1
Device Expiration Issue 1 1
Unintended Ejection 1 1
Loss of or Failure to Bond 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Chemical Problem 1 1
Separation Failure 1 1
Folded 1 1
Solder Joint Fracture 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Shelf Life Exceeded 1 1
Shipping Damage or Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Unraveled Material 1 1
Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 1164 1164
Pain 415 415
No Clinical Signs, Symptoms or Conditions 350 350
Non-union Bone Fracture 339 339
Unspecified Infection 337 337
Failure of Implant 331 331
Bone Fracture(s) 326 326
No Consequences Or Impact To Patient 246 246
No Known Impact Or Consequence To Patient 242 242
Injury 152 152
Post Operative Wound Infection 132 132
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 126 126
Impaired Healing 125 125
No Patient Involvement 115 115
Necrosis 112 112
Physical Asymmetry 54 54
Discomfort 45 45
Loss of Range of Motion 42 42
No Information 32 32
Insufficient Information 26 26
Foreign Body In Patient 26 26
Unspecified Tissue Injury 25 25
Malunion of Bone 24 24
Joint Dislocation 23 23
Reaction 20 20
Hypersensitivity/Allergic reaction 20 20
Nerve Damage 19 19
Not Applicable 19 19
Device Embedded In Tissue or Plaque 17 17
Deformity/ Disfigurement 15 15
Wound Dehiscence 15 15
Blood Loss 14 14
Arthritis 13 13
Sepsis 12 12
Hematoma 12 12
Fluid Discharge 11 11
Death 10 10
Fall 9 9
Skin Erosion 9 9
Bacterial Infection 8 8
Patient Problem/Medical Problem 8 8
Limb Fracture 8 8
Discharge 7 7
Thrombosis 7 7
Inflammation 7 7
Paralysis 6 6
Swelling 6 6
Ambulation Difficulties 6 6
Irritation 5 5
Hemorrhage/Bleeding 5 5
Pulmonary Embolism 5 5
Skin Inflammation/ Irritation 5 5
Swelling/ Edema 4 4
Cyst(s) 4 4
Tissue Damage 4 4
Perforation 3 3
Weakness 3 3
Spinal Cord Injury 3 3
Osteolysis 3 3
Hypoesthesia 3 3
Limited Mobility Of The Implanted Joint 3 3
Skin Irritation 3 3
Erosion 2 2
Fever 2 2
Foreign Body Sensation in Eye 2 2
Sedation 2 2
Tingling 2 2
Implant Pain 2 2
Drug Resistant Bacterial Infection 1 1
Metal Related Pathology 1 1
Embolism/Embolus 1 1
Hip Fracture 1 1
Disability 1 1
Burning Sensation 1 1
Ulcer 1 1
Visual Disturbances 1 1
Tissue Breakdown 1 1
Numbness 1 1
Bronchopneumonia 1 1
Fatigue 1 1
Embolism 1 1
Erythema 1 1
Eye Injury 1 1
Calcium Deposits/Calcification 1 1
Cardiac Arrest 1 1
Cellulitis 1 1
Congenital Defect/Deformity 1 1
Ossification 1 1
Seroma 1 1
Paresis 1 1
Itching Sensation 1 1
Damage to Ligament(s) 1 1
Muscular Rigidity 1 1
Myocardial Infarction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medicalplastic S.R.L. II Nov-17-2021
2 Orthofix Srl II Nov-14-2019
3 Orthofix Srl II Jun-05-2018
4 Orthofix Srl II Dec-27-2017
5 Stryker GmbH II Oct-29-2018
6 Stryker GmbH II Sep-22-2018
7 Stryker GmbH II Apr-26-2018
8 Stryker Howmedica Osteonics Corp. II May-25-2017
9 Zimmer Biomet, Inc. II Nov-22-2019
10 Zimmer Biomet, Inc. II Nov-07-2019
11 Zimmer Biomet, Inc. II Jun-15-2017
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