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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pin, fixation, threaded
Product CodeJDW
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
EISERTECH, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYNTEC SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TINAVI (ANHUI) MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 575 575
2020 402 402
2021 168 168
2022 124 124
2023 74 74
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 862 862
Break 96 96
Insufficient Information 80 80
Fracture 48 48
Migration 43 43
Mechanical Problem 42 42
Patient Device Interaction Problem 29 29
Device Markings/Labelling Problem 23 23
Material Deformation 20 20
Material Fragmentation 18 18
Appropriate Term/Code Not Available 17 17
Loose or Intermittent Connection 15 15
Patient-Device Incompatibility 15 15
Malposition of Device 14 14
Device Dislodged or Dislocated 11 11
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Device-Device Incompatibility 10 10
Inadequacy of Device Shape and/or Size 8 8
Unintended Movement 7 7
Detachment of Device or Device Component 5 5
Naturally Worn 5 5
Entrapment of Device 4 4
Packaging Problem 4 4
Mechanical Jam 4 4
No Apparent Adverse Event 3 3
Device Slipped 3 3
Defective Component 3 3
Loss of Osseointegration 3 3
Material Split, Cut or Torn 3 3
Physical Resistance/Sticking 3 3
Protective Measures Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Human-Device Interface Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
Mechanics Altered 1 1
Material Twisted/Bent 1 1
Defective Device 1 1
Fitting Problem 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Corroded 1 1
Crack 1 1
Delivered as Unsterile Product 1 1
Peeled/Delaminated 1 1
Difficult to Remove 1 1
Self-Activation or Keying 1 1
Shipping Damage or Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 471 471
Injury 193 193
Post Operative Wound Infection 119 119
No Clinical Signs, Symptoms or Conditions 111 111
No Known Impact Or Consequence To Patient 73 73
No Code Available 73 73
Bacterial Infection 71 71
Inflammation 52 52
Non-union Bone Fracture 52 52
No Information 51 51
Pain 39 39
Failure of Implant 38 38
Insufficient Information 32 32
Erythema 24 24
Nerve Damage 23 23
Bone Fracture(s) 22 22
Foreign Body In Patient 21 21
No Consequences Or Impact To Patient 18 18
Deformity/ Disfigurement 16 16
Loss of Range of Motion 12 12
Irritation 12 12
Device Embedded In Tissue or Plaque 11 11
Malunion of Bone 11 11
Skin Infection 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Impaired Healing 10 10
Perforation 9 9
Swelling 9 9
Thrombosis 9 9
Osteomyelitis 9 9
Tissue Breakdown 7 7
Discharge 6 6
Tissue Damage 6 6
Hematoma 6 6
Purulent Discharge 6 6
Arthritis 6 6
Cellulitis 5 5
Ossification 5 5
Hemorrhage/Bleeding 5 5
Ambulation Difficulties 5 5
Fluid Discharge 5 5
Joint Dislocation 4 4
Fall 4 4
Pulmonary Embolism 4 4
Abscess 4 4
Necrosis 4 4
Tingling 3 3
Scar Tissue 3 3
Thrombosis/Thrombus 3 3
Joint Contracture 3 3
No Patient Involvement 2 2
Wound Dehiscence 2 2
Death 1 1
Aneurysm 1 1
Embolism 1 1
Hypersensitivity/Allergic reaction 1 1
Granuloma 1 1
Renal Failure 1 1
Paresis 1 1
Muscular Rigidity 1 1
Numbness 1 1
Fibrosis 1 1
Not Applicable 1 1
Limb Fracture 1 1
Subluxation 1 1
Swollen Lymph Nodes/Glands 1 1
Sepsis 1 1
Rupture 1 1
Hernia 1 1
Ulcer 1 1
Complaint, Ill-Defined 1 1
Hip Fracture 1 1
Fracture, Arm 1 1
Vascular System (Circulation), Impaired 1 1
Pseudoaneurysm 1 1
Unequal Limb Length 1 1
Localized Skin Lesion 1 1
Drug Resistant Bacterial Infection 1 1
Unspecified Tissue Injury 1 1
External Prosthetic Device Pain 1 1
Implant Pain 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Orthofix Srl II Nov-14-2019
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