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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 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 884 884
Break 102 102
Insufficient Information 80 80
Fracture 57 57
Mechanical Problem 45 45
Migration 45 45
Patient Device Interaction Problem 35 35
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-Device Incompatibility 11 11
Device Dislodged or Dislocated 11 11
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Inadequacy of Device Shape and/or Size 8 8
Unintended Movement 7 7
Naturally Worn 5 5
Entrapment of Device 5 5
Detachment of Device or Device Component 5 5
Mechanical Jam 4 4
Physical Resistance/Sticking 4 4
Packaging Problem 4 4
Loss of Osseointegration 3 3
No Apparent Adverse Event 3 3
Contamination /Decontamination Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Defective Component 3 3
Material Split, Cut or Torn 3 3
Device Slipped 3 3
Material Twisted/Bent 2 2
Separation Failure 2 2
Protective Measures Problem 2 2
Human-Device Interface Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Use of Device Problem 1 1
Shipping Damage or Problem 1 1
Mechanics Altered 1 1
Difficult to Remove 1 1
Delivered as Unsterile Product 1 1
Difficult or Delayed Separation 1 1
Defective Device 1 1
Peeled/Delaminated 1 1
Crack 1 1
Activation, Positioning or Separation Problem 1 1
Nonstandard Device 1 1
Connection Problem 1 1
Self-Activation or Keying 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 475 475
Injury 193 193
Post Operative Wound Infection 121 121
No Clinical Signs, Symptoms or Conditions 120 120
Bacterial Infection 78 78
No Code Available 73 73
No Known Impact Or Consequence To Patient 73 73
Non-union Bone Fracture 59 59
Inflammation 53 53
No Information 51 51
Pain 41 41
Failure of Implant 41 41
Insufficient Information 37 37
Foreign Body In Patient 25 25
Erythema 24 24
Nerve Damage 23 23
Bone Fracture(s) 23 23
Deformity/ Disfigurement 20 20
No Consequences Or Impact To Patient 18 18
Loss of Range of Motion 15 15
Malunion of Bone 13 13
Device Embedded In Tissue or Plaque 12 12
Irritation 12 12
Impaired Healing 11 11
Skin Infection 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Perforation 11 11
Osteomyelitis 10 10
Thrombosis 9 9
Swelling 9 9
Tissue Breakdown 7 7
Cellulitis 6 6
Purulent Discharge 6 6
Hematoma 6 6
Arthritis 6 6
Discharge 6 6
Tissue Damage 6 6
Ossification 5 5
Ambulation Difficulties 5 5
Fluid Discharge 5 5
Hemorrhage/Bleeding 5 5
Joint Contracture 5 5
Necrosis 4 4
Pulmonary Embolism 4 4
Joint Dislocation 4 4
Fall 4 4
Abscess 4 4
Thrombosis/Thrombus 3 3
Scar Tissue 3 3
Tingling 3 3

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