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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
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeJDW
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
BIODYNAMIK, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDULOC, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 168 168
2022 121 134
2023 72 72
2024 65 65
2025 29 29
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 243 254
Break 48 48
Fracture 45 45
Patient Device Interaction Problem 24 24
Device Markings/Labelling Problem 22 22
Mechanical Problem 21 21
Material Deformation 18 18
Material Fragmentation 16 16
Migration 13 13
Inadequacy of Device Shape and/or Size 8 8
Naturally Worn 5 5
Device-Device Incompatibility 5 5
Detachment of Device or Device Component 4 4
Packaging Problem 4 4
Mechanical Jam 3 4
Appropriate Term/Code Not Available 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Entrapment of Device 3 3
Material Split, Cut or Torn 3 3
Device Slipped 3 3
Contamination /Decontamination Problem 2 2
Separation Failure 2 2
Delivered as Unsterile Product 2 2
Physical Resistance/Sticking 2 2
Device Dislodged or Dislocated 2 3
Defective Device 1 1
Defective Component 1 1
Insufficient Information 1 1
Shipping Damage or Problem 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Peeled/Delaminated 1 1
Crack 1 1
Difficult or Delayed Separation 1 1
Incomplete or Missing Packaging 1 1
No Apparent Adverse Event 1 1
Protective Measures Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Nonstandard Device 1 1
Fitting Problem 1 1
Self-Activation or Keying 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 113 114
Bacterial Infection 68 68
Unspecified Infection 64 73
Insufficient Information 33 34
Failure of Implant 29 30
Non-union Bone Fracture 27 27
Post Operative Wound Infection 18 18
Foreign Body In Patient 18 18
Malunion of Bone 17 17
Pain 16 16
Skin Infection 11 11
Deformity/ Disfigurement 11 11
Bone Fracture(s) 10 10
Osteomyelitis 10 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Loss of Range of Motion 7 7
Hematoma 6 6
Impaired Healing 5 5
Device Embedded In Tissue or Plaque 5 5
Joint Contracture 4 4
Nerve Damage 4 6
Scar Tissue 3 3
Ossification 3 3
Inflammation 3 4
Necrosis 3 3
Tissue Breakdown 2 2
Cellulitis 2 2
Localized Skin Lesion 2 2
Perforation 2 2
Ambulation Difficulties 2 2
Pseudoaneurysm 2 2
Wound Dehiscence 2 2
Granuloma 1 1
Arthritis 1 1
Fibrosis 1 1
Swollen Lymph Nodes/Glands 1 1
Pulmonary Embolism 1 1
External Prosthetic Device Pain 1 1
Ulcer 1 1
Aneurysm 1 1
Swelling/ Edema 1 1
Unspecified Tissue Injury 1 1
Joint Laxity 1 1
Renal Failure 1 1
Subluxation 1 1
Limb Fracture 1 1
Abscess 1 1
Paresis 1 1
Unequal Limb Length 1 1
Hernia 1 1

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