Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
SUMMIT MEDVENTURES
  SUBSTANTIALLY EQUIVALENT 1
SYNTEC SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TINAVI (ANHUI) MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 94 94
2019 575 575
2020 403 403
2021 168 168
2022 125 125
2023 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 835 835
Break 114 114
Insufficient Information 86 86
Patient Device Interaction Problem 57 57
Fracture 47 47
Mechanical Problem 45 45
Migration 42 42
Device Markings/Labelling Problem 23 23
Material Deformation 20 20
Appropriate Term/Code Not Available 18 18
Material Fragmentation 18 18
Patient-Device Incompatibility 16 16
Loose or Intermittent Connection 15 15
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
Entrapment of Device 5 5
Product Quality Problem 4 4
Contamination 4 4
Detachment of Device or Device Component 4 4
Packaging Problem 4 4
No Apparent Adverse Event 3 3
Physical Resistance/Sticking 3 3
Device Slipped 3 3
Loss of Osseointegration 3 3
Defective Component 3 3
Bent 3 3
Crack 3 3
Material Split, Cut or Torn 2 2
Protective Measures Problem 2 2
Human-Device Interface Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Difficult to Advance 2 2
Material Twisted/Bent 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Mechanics Altered 1 1
Material Frayed 1 1
Corroded 1 1
Detachment Of Device Component 1 1
Difficult to Remove 1 1
Shelf Life Exceeded 1 1
Shipping Damage or Problem 1 1
Delivered as Unsterile Product 1 1
Peeled/Delaminated 1 1
Microbial Contamination of Device 1 1
Tear, Rip or Hole in Device Packaging 1 1
Defective Device 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Device Contamination With Biological Material 1 1
Device Damaged by Another Device 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 462 462
Injury 199 199
Post Operative Wound Infection 113 113
No Clinical Signs, Symptoms or Conditions 99 99
Bacterial Infection 99 99
No Known Impact Or Consequence To Patient 88 88
No Code Available 87 87
No Information 55 55
Inflammation 53 53
Non-union Bone Fracture 44 44
Pain 41 41
Failure of Implant 35 35
Insufficient Information 27 27
Erythema 24 24
Nerve Damage 23 23
Foreign Body In Patient 23 23
No Consequences Or Impact To Patient 22 22
Bone Fracture(s) 21 21
Device Embedded In Tissue or Plaque 18 18
Deformity/ Disfigurement 14 14
Irritation 12 12
Skin Infection 11 11
Loss of Range of Motion 10 10
Swelling 10 10
Thrombosis 9 9
Impaired Healing 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Perforation 9 9
Tissue Breakdown 7 7
Discharge 6 6
Arthritis 6 6
Tissue Damage 6 6
Purulent Discharge 6 6
Ambulation Difficulties 5 5
Fluid Discharge 5 5
Hemorrhage/Bleeding 5 5
Cellulitis 5 5
Pulmonary Embolism 4 4
Joint Dislocation 4 4
Necrosis 4 4
Fall 4 4
Hematoma 4 4
Abscess 4 4
Tingling 3 3
Joint Contracture 3 3
No Patient Involvement 3 3
Scar Tissue 3 3
Thrombosis/Thrombus 3 3
Osteomyelitis 3 3
Ossification 2 2
Oversedation 2 2
Wound Dehiscence 2 2
Aneurysm 1 1
Rupture 1 1
Hernia 1 1
Fracture, Arm 1 1
Numbness 1 1
Embolism 1 1
Granuloma 1 1
Unequal Limb Length 1 1
Discomfort 1 1
Swelling/ Edema 1 1
Pseudoaneurysm 1 1
Hypersensitivity/Allergic reaction 1 1
Renal Failure 1 1
Complaint, Ill-Defined 1 1
Fibrosis 1 1
Swollen Lymph Nodes/Glands 1 1
Ulcer 1 1
Hip Fracture 1 1
Sepsis 1 1
Burn(s) 1 1
Paresis 1 1
Death 1 1
Muscular Rigidity 1 1
Vascular System (Circulation), Impaired 1 1
Not Applicable 1 1
Implant Pain 1 1
Subluxation 1 1
Malunion of Bone 1 1
Localized Skin Lesion 1 1

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