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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device staple, fixation, bone
Product CodeJDR
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTEMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SOLUTIONS UK LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28 INC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
RMR ORTHO, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 3
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 242 242
2020 234 234
2021 210 210
2022 202 209
2023 175 175
2024 131 131

Device Problems MDRs with this Device Problem Events in those MDRs
Break 355 355
Adverse Event Without Identified Device or Use Problem 261 265
Detachment of Device or Device Component 124 124
Fracture 78 78
Migration 35 38
Device-Device Incompatibility 32 32
Device Dislodged or Dislocated 32 32
Manufacturing, Packaging or Shipping Problem 29 29
Physical Resistance/Sticking 23 23
Difficult to Advance 22 22
Material Split, Cut or Torn 19 19
Appropriate Term/Code Not Available 17 17
Material Separation 17 17
Crack 16 16
Migration or Expulsion of Device 16 16
Loosening of Implant Not Related to Bone-Ingrowth 15 15
Patient Device Interaction Problem 13 13
Insufficient Information 13 13
Entrapment of Device 9 9
Material Frayed 9 9
Material Deformation 8 8
Material Twisted/Bent 7 7
Failure to Advance 6 6
Material Fragmentation 6 6
No Apparent Adverse Event 6 6
Difficult to Remove 5 5
Unintended Movement 5 5
Mechanical Problem 4 4
Patient-Device Incompatibility 4 4
Activation Problem 4 4
Loose or Intermittent Connection 4 4
Device Damaged by Another Device 4 4
Inaccurate Information 4 4
Mechanical Jam 4 4
Material Integrity Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Defective Component 3 3
Corroded 3 3
Delivered as Unsterile Product 3 3
Packaging Problem 3 3
Connection Problem 3 3
Firing Problem 2 2
Fitting Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Activation, Positioning or Separation Problem 2 2
Flaked 2 2
Inadequacy of Device Shape and/or Size 2 2
Failure to Form Staple 2 2
Difficult or Delayed Positioning 2 2
Failure to Cut 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 470 470
No Consequences Or Impact To Patient 104 104
Pain 87 87
Non-union Bone Fracture 64 64
No Code Available 59 59
Insufficient Information 56 56
Injury 55 55
Tissue Damage 48 48
Failure of Implant 47 47
Not Applicable 45 45
No Known Impact Or Consequence To Patient 41 41
Foreign Body In Patient 34 34
Unspecified Infection 28 28
Unspecified Tissue Injury 23 23
Loss of Range of Motion 21 24
Bone Fracture(s) 21 21
No Patient Involvement 19 19
Post Operative Wound Infection 19 19
Perforation 15 15
Impaired Healing 14 14
No Information 13 13
Implant Pain 12 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Discomfort 11 11
Hypersensitivity/Allergic reaction 9 9
Wound Dehiscence 8 8
Device Embedded In Tissue or Plaque 5 5
Foreign Body Reaction 5 5
Cyst(s) 4 4
Hematoma 4 4
Inflammation 4 4
Rupture 4 4
Malunion of Bone 4 4
Abscess 4 4
Fall 4 4
Joint Dislocation 4 4
Skin Inflammation/ Irritation 3 3
Synovitis 3 3
Arthritis 3 3
Cellulitis 3 3
Skin Infection 3 3
Swelling/ Edema 3 3
Osteolysis 3 3
Erosion 2 2
Bacterial Infection 2 2
Physical Asymmetry 2 2
Ulcer 2 2
Muscle/Tendon Damage 2 2
Stroke/CVA 2 2
Numbness 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-18-2022
2 Merete Medical GmbH II Feb-17-2022
3 Stryker GmbH II Nov-16-2020
4 Synthes (USA) Products LLC II Oct-18-2022
5 Synthes (USA) Products LLC II Oct-06-2022
6 Wright Medical Technology, Inc. II Mar-31-2022
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