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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
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
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
ASCENSION ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
AUSTIN MILLER TRAUMA LLC
  SUBSTANTIALLY EQUIVALENT 1
CITIEFFE S.R.L
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
DNE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GEXFIX INTERNATIONAL CORP.
  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
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, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 5
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S
  SUBSTANTIALLY EQUIVALENT 1
VILEX IN TENNESSEE, INC
  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 2

MDR Year MDR Reports MDR Events
2016 400 400
2017 485 485
2018 597 597
2019 800 800
2020 941 941
2021 715 715

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1628 1628
Break 662 662
Device-Device Incompatibility 241 241
Migration 233 233
Mechanical Problem 172 172
Unintended Movement 102 102
Fracture 91 91
Insufficient Information 90 90
Device Operates Differently Than Expected 76 76
Migration or Expulsion of Device 69 69
Device Slipped 58 58
Material Twisted/Bent 58 58
Material Deformation 58 58
Appropriate Term/Code Not Available 47 47
Mechanical Jam 45 45
No Apparent Adverse Event 35 35
Fitting Problem 31 31
Loose or Intermittent Connection 25 25
Manufacturing, Packaging or Shipping Problem 23 23
Use of Device Problem 22 22
Crack 21 21
Loosening of Implant Not Related to Bone-Ingrowth 18 18
Corroded 17 17
Detachment Of Device Component 16 16
Loss of Osseointegration 16 16
Contamination /Decontamination Problem 15 15
Device Dislodged or Dislocated 15 15
Detachment of Device or Device Component 15 15
Failure to Align 15 15
Difficult to Remove 14 14
Defective Device 13 13
Bent 13 13
Material Fragmentation 13 13
Patient Device Interaction Problem 13 13
Component Falling 12 12
Difficult to Insert 11 11
Improper or Incorrect Procedure or Method 9 9
Failure to Osseointegrate 8 8
Patient-Device Incompatibility 7 7
Connection Problem 7 7
Device Inoperable 7 7
Entrapment of Device 7 7
Failure To Adhere Or Bond 6 6
Positioning Problem 6 6
Naturally Worn 6 6
Nonstandard Device 6 6
Material Separation 5 5
Component Missing 5 5
Material Integrity Problem 5 5
Physical Resistance/Sticking 5 5
Difficult to Advance 5 5
Peeled/Delaminated 5 5
Material Discolored 5 5
Disconnection 4 4
Difficult or Delayed Positioning 4 4
Device Markings/Labelling Problem 4 4
Malposition of Device 4 4
Unstable 4 4
Incomplete or Inadequate Connection 4 4
Device Difficult to Maintain 4 4
Device Difficult to Setup or Prepare 4 4
Device Damaged by Another Device 4 4
Failure to Cut 3 3
Microbial Contamination of Device 3 3
Positioning Failure 3 3
Failure to Advance 3 3
Device Damaged Prior to Use 3 3
Computer Software Problem 3 3
Material Frayed 2 2
Defective Component 2 2
Sticking 2 2
Dull, Blunt 2 2
Device Contaminated During Manufacture or Shipping 2 2
Degraded 2 2
Device Expiration Issue 2 2
Material Too Rigid or Stiff 2 2
Device Operational Issue 2 2
Application Program Problem 2 2
Packaging Problem 2 2
Physical Property Issue 2 2
Therapeutic or Diagnostic Output Failure 1 1
Noise, Audible 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Failure to Eject 1 1
Activation Problem 1 1
Difficult or Delayed Separation 1 1
Material Puncture/Hole 1 1
Obstruction of Flow 1 1
Shelf Life Exceeded 1 1
Shipping Damage or Problem 1 1
Folded 1 1
Separation Failure 1 1
Unintended Ejection 1 1
Unsealed Device Packaging 1 1
Difficult To Position 1 1
Premature Activation 1 1
Material Disintegration 1 1
Loss of or Failure to Bond 1 1
Component Incompatible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 1302 1302
Pain 448 448
Failure of Implant 397 397
Unspecified Infection 386 386
Non-union Bone Fracture 358 358
Bone Fracture(s) 319 319
No Known Impact Or Consequence To Patient 308 308
No Consequences Or Impact To Patient 282 282
No Clinical Signs, Symptoms or Conditions 277 277
Impaired Healing 163 163
Injury 152 152
No Patient Involvement 121 121
Necrosis 116 116
Post Operative Wound Infection 103 103
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 92 92
No Information 53 53
Discomfort 47 47
Physical Asymmetry 47 47
Loss of Range of Motion 41 41
Foreign Body In Patient 25 25
Device Embedded In Tissue or Plaque 25 25
Unspecified Tissue Injury 25 25
Reaction 23 23
Nerve Damage 21 21
Not Applicable 21 21
Insufficient Information 18 18
Joint Dislocation 17 17
Swelling 16 16
Hypersensitivity/Allergic reaction 15 15
Wound Dehiscence 15 15
Malunion of Bone 15 15
Blood Loss 14 14
Fall 14 14
Deformity/ Disfigurement 14 14
Sedation 13 13
Hematoma 13 13
Arthritis 13 13
Sepsis 12 12
Fluid Discharge 11 11
Death 10 10
Bacterial Infection 8 8
Patient Problem/Medical Problem 8 8
Limb Fracture 8 8
Skin Erosion 8 8
Thrombosis 7 7
Discharge 7 7
Paralysis 7 7
Inflammation 6 6
Ambulation Difficulties 6 6
Irritation 5 5
Pulmonary Embolism 5 5
Hemorrhage/Bleeding 5 5
Skin Inflammation/ Irritation 5 5
Tissue Damage 4 4
Cyst(s) 4 4
Osteolysis 3 3
Skin Irritation 3 3
Hypoesthesia 3 3
Weakness 3 3
Limited Mobility Of The Implanted Joint 3 3
Swelling/ Edema 3 3
Tingling 2 2
Ossification 2 2
Foreign Body Sensation in Eye 2 2
Perforation 2 2
Rash 2 2
Erosion 2 2
Fever 2 2
Fatigue 1 1
Paresis 1 1
Calcium Deposits/Calcification 1 1
Congenital Defect/Deformity 1 1
Erythema 1 1
Visual Disturbances 1 1
Numbness 1 1
Ulcer 1 1
Hip Fracture 1 1
Embolism/Embolus 1 1
Metal Related Pathology 1 1
Cardiac Arrest 1 1
Cellulitis 1 1
Embolism 1 1
Eye Injury 1 1
Seroma 1 1
Itching Sensation 1 1
Damage to Ligament(s) 1 1
Muscular Rigidity 1 1
Myocardial Infarction 1 1
Burning Sensation 1 1
Bronchopneumonia 1 1
Disability 1 1
Tissue Breakdown 1 1
Intraoperative Pain 1 1
Implant Pain 1 1
Drug Resistant Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 Integra LifeSciences Corp. II Aug-11-2016
3 Integra LifeSciences Corp. II Jul-27-2016
4 Orthofix Srl II Nov-14-2019
5 Orthofix Srl II Jun-05-2018
6 Orthofix Srl II Dec-27-2017
7 Stryker GmbH II Oct-29-2018
8 Stryker GmbH II Sep-22-2018
9 Stryker GmbH II Apr-26-2018
10 Stryker Howmedica Osteonics Corp. II May-25-2017
11 Zimmer Biomet, Inc. II Nov-22-2019
12 Zimmer Biomet, Inc. II Nov-07-2019
13 Zimmer Biomet, Inc. II Jun-15-2017
14 Zimmer Manufacturing B.V. II May-16-2016
15 Zimmer Manufacturing B.V. II Mar-12-2016
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