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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 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 871 871
Break 100 100
Insufficient Information 80 80
Fracture 54 54
Migration 44 44
Mechanical Problem 42 42
Patient Device Interaction Problem 30 30
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
Mechanical Jam 4 4
Entrapment of Device 4 4
Packaging Problem 4 4
No Apparent Adverse Event 3 3
Material Split, Cut or Torn 3 3
Physical Resistance/Sticking 3 3
Device Slipped 3 3
Defective Component 3 3
Loss of Osseointegration 3 3
Human-Device Interface Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Protective Measures Problem 2 2
Difficult or Delayed Separation 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Mechanics Altered 1 1
Material Twisted/Bent 1 1
Separation Failure 1 1
Defective Device 1 1
Fitting Problem 1 1
Corroded 1 1
Crack 1 1
Nonstandard Device 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 472 472
Injury 193 193
Post Operative Wound Infection 119 119
No Clinical Signs, Symptoms or Conditions 115 115
No Code Available 73 73
No Known Impact Or Consequence To Patient 73 73
Bacterial Infection 72 72
Non-union Bone Fracture 58 58
Inflammation 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
Foreign Body In Patient 23 23
Bone Fracture(s) 22 22
Deformity/ Disfigurement 20 20
No Consequences Or Impact To Patient 18 18
Loss of Range of Motion 14 14
Irritation 12 12
Device Embedded In Tissue or Plaque 12 12
Perforation 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
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 Contracture 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
No Patient Involvement 2 2
Wound Dehiscence 2 2
Localized Skin Lesion 2 2
Unequal Limb Length 1 1
Swollen Lymph Nodes/Glands 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
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
Joint Laxity 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

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