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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 2
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT MEDVENTURES
  SUBSTANTIALLY EQUIVALENT 1
SYNTEC SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TINAVI (ANHUI) MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VILEX IN TENNESSEE, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 43 43
2018 94 94
2019 575 575
2020 403 403
2021 168 168
2022 84 84

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 808 808
Break 116 116
Insufficient Information 86 86
Patient Device Interaction Problem 58 58
Mechanical Problem 52 52
Fracture 49 49
Migration 37 37
Device Markings/Labelling Problem 23 23
Material Deformation 20 20
Material Fragmentation 19 19
Appropriate Term/Code Not Available 18 18
Loose or Intermittent Connection 16 16
Patient-Device Incompatibility 16 16
Malposition of Device 14 14
Device-Device Incompatibility 11 11
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Device Dislodged or Dislocated 10 10
Dull, Blunt 9 9
Inadequacy of Device Shape and/or Size 8 8
Unintended Movement 7 7
Naturally Worn 5 5
Mechanical Jam 5 5
Detachment of Device or Device Component 4 4
Packaging Problem 4 4
Entrapment of Device 4 4
Bent 4 4
Contamination 4 4
Product Quality Problem 4 4
Detachment Of Device Component 3 3
Crack 3 3
Loss of Osseointegration 3 3
Device Slipped 3 3
Defective Component 3 3
No Apparent Adverse Event 3 3
Physical Resistance/Sticking 3 3
Human-Device Interface Problem 3 3
Device Contaminated During Manufacture or Shipping 2 2
Difficult to Advance 2 2
Material Twisted/Bent 2 2
Material Split, Cut or Torn 2 2
Protective Measures Problem 2 2
Mechanics Altered 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Contamination With Biological Material 1 1
Device Damaged by Another Device 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Material Frayed 1 1
Corroded 1 1
Difficult to Remove 1 1
Shelf Life Exceeded 1 1
Shipping Damage or Problem 1 1
Migration or Expulsion of Device 1 1
Delivered as Unsterile Product 1 1
Peeled/Delaminated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 456 456
Injury 199 199
Post Operative Wound Infection 113 113
No Code Available 104 104
No Clinical Signs, Symptoms or Conditions 94 94
No Known Impact Or Consequence To Patient 92 92
Bacterial Infection 69 69
No Information 56 56
Inflammation 53 53
Non-union Bone Fracture 44 44
Pain 41 41
Failure of Implant 29 29
No Consequences Or Impact To Patient 27 27
Device Embedded In Tissue or Plaque 26 26
Erythema 24 24
Nerve Damage 23 23
Foreign Body In Patient 22 22
Bone Fracture(s) 21 21
Insufficient Information 20 20
Deformity/ Disfigurement 14 14
Irritation 12 12
Skin Infection 11 11
Swelling 10 10
Impaired Healing 10 10
Loss of Range of Motion 10 10
Perforation 9 9
Thrombosis 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Tissue Breakdown 7 7
Discharge 6 6
Tissue Damage 6 6
Arthritis 6 6
Purulent Discharge 6 6
Cellulitis 5 5
Hemorrhage/Bleeding 5 5
Fluid Discharge 5 5
Ambulation Difficulties 5 5
Joint Dislocation 4 4
Necrosis 4 4
Pulmonary Embolism 4 4
Abscess 4 4
Fall 4 4
Hematoma 4 4
Tingling 3 3
No Patient Involvement 3 3
Thrombosis/Thrombus 3 3
Hip Fracture 2 2
Oversedation 2 2
Wound Dehiscence 2 2
Ossification 2 2
Joint Contracture 2 2
Osteomyelitis 2 2
Unequal Limb Length 1 1
Localized Skin Lesion 1 1
Malunion of Bone 1 1
Implant Pain 1 1
Swelling/ Edema 1 1
Aneurysm 1 1
Death 1 1
Burn(s) 1 1
Granuloma 1 1
Embolism 1 1
Paresis 1 1
Hypersensitivity/Allergic reaction 1 1
Muscular Rigidity 1 1
Fracture, Arm 1 1
Numbness 1 1
Hernia 1 1
Ulcer 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Renal Failure 1 1
Scar Tissue 1 1
Rupture 1 1
Subluxation 1 1
Swollen Lymph Nodes/Glands 1 1
Fibrosis 1 1
Not Applicable 1 1
Vascular System (Circulation), Impaired 1 1
Pseudoaneurysm 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Orthofix Srl II Nov-14-2019
2 Zimmer Biomet, Inc. II Dec-29-2017
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