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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 2
AUSTIN & ASSOCIATES, INC./TELOS MEDICAL EQUIPMENT
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTEMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2
DALLEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPIC EXTREMELY, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXOTOE LLC
  SUBSTANTIALLY EQUIVALENT 1
F & A FOUNDATION LLC D.B.A. REIGN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FIRST RAY LLC
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS, 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 3
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
ORTHOVESTMENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28 INC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
RESTORE SURGICAL LLC DBA INSTRATEK
  SUBSTANTIALLY EQUIVALENT 1
RMR ORTHO, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
TREACE MEDICAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 2
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TRILLIANT SURGICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
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
2017 116 116
2018 239 239
2019 242 242
2020 234 234
2021 210 210
2022 202 209
2023 175 175
2024 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Break 487 487
Adverse Event Without Identified Device or Use Problem 264 268
Detachment of Device or Device Component 131 131
Fracture 86 86
Material Frayed 37 37
Migration 35 38
Device Dislodged or Dislocated 34 34
Migration or Expulsion of Device 33 33
Device-Device Incompatibility 31 31
Manufacturing, Packaging or Shipping Problem 29 29
Appropriate Term/Code Not Available 27 27
Insufficient Information 23 23
Material Split, Cut or Torn 23 23
Difficult to Advance 23 23
Physical Resistance/Sticking 19 19
Material Separation 17 17
Crack 15 15
Loosening of Implant Not Related to Bone-Ingrowth 15 15
Device Operates Differently Than Expected 13 13
Material Deformation 11 11
Activation, Positioning or Separation Problem 9 9
Entrapment of Device 9 9
Positioning Failure 8 8
Patient Device Interaction Problem 8 8
Mechanical Jam 8 8
Unintended Movement 7 7
Difficult to Insert 7 7
Material Fragmentation 7 7
Detachment Of Device Component 7 7
Improper or Incorrect Procedure or Method 6 6
Failure to Advance 6 6
No Apparent Adverse Event 6 6
Packaging Problem 6 6
Device Contaminated During Manufacture or Shipping 5 5
Material Twisted/Bent 5 5
Patient-Device Incompatibility 5 5
Separation Failure 5 5
Component Falling 5 5
Difficult or Delayed Positioning 5 5
Mechanical Problem 5 5
Difficult to Remove 5 5
Material Rupture 4 4
Difficult To Position 4 4
Device Slipped 4 4
Loose or Intermittent Connection 4 4
Failure to Form Staple 4 4
Device Damaged by Another Device 4 4
Connection Problem 4 4
Activation Problem 4 4
Inaccurate Information 4 4
Component Missing 3 3
Bent 3 3
Corroded 3 3
Delivered as Unsterile Product 3 3
Flaked 2 2
Overheating of Device 2 2
Defective Component 2 2
Failure to Align 2 2
Inadequacy of Device Shape and/or Size 2 2
Failure to Cut 2 2
Contamination /Decontamination Problem 2 2
Device Markings/Labelling Problem 2 2
Material Integrity Problem 2 2
Device Fell 2 2
Failure to Eject 2 2
Firing Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Difficult to Maintain 1 1
Moisture or Humidity Problem 1 1
Positioning Problem 1 1
Temperature Problem 1 1
Output Problem 1 1
Material Protrusion/Extrusion 1 1
Expulsion 1 1
Device Contamination with Chemical or Other Material 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Operational Issue 1 1
Expiration Date Error 1 1
Misfire 1 1
Defective Device 1 1
Failure to Fire 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Tear, Rip or Hole in Device Packaging 1 1
Loss of Osseointegration 1 1
Output above Specifications 1 1
Melted 1 1
Nonstandard Device 1 1
Sticking 1 1
Stretched 1 1
Device Inoperable 1 1
Unstable 1 1
Use of Device Problem 1 1
Off-Label Use 1 1
Degraded 1 1
Disassembly 1 1
Material Disintegration 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 428 428
No Consequences Or Impact To Patient 224 224
No Known Impact Or Consequence To Patient 163 163
Pain 93 93
No Code Available 91 91
Non-union Bone Fracture 69 69
Injury 63 63
Tissue Damage 59 59
Failure of Implant 57 57
Not Applicable 56 56
Foreign Body In Patient 46 46
Insufficient Information 46 46
Unspecified Infection 34 34
Loss of Range of Motion 25 28
No Patient Involvement 24 24
Unspecified Tissue Injury 23 23
Bone Fracture(s) 22 22
No Information 21 21
Impaired Healing 18 18
Post Operative Wound Infection 17 17
Perforation 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Discomfort 11 11
Implant Pain 11 15
Device Embedded In Tissue or Plaque 9 9
Reaction 8 8
Hypersensitivity/Allergic reaction 8 8
Wound Dehiscence 8 8
Foreign Body Reaction 5 5
Osteolysis 5 5
Patient Problem/Medical Problem 5 5
Malunion of Bone 4 4
Joint Dislocation 4 4
Rupture 4 4
Hematoma 4 4
Cyst(s) 4 4
Fall 4 4
Abscess 4 4
Inflammation 4 4
Swelling 4 4
Synovitis 3 3
Weakness 3 3
Arthritis 3 3
Cellulitis 3 3
Nerve Damage 3 3
Skin Infection 3 3
Swelling/ Edema 3 3
Skin Inflammation/ Irritation 2 2
Physical Asymmetry 2 2
Ulcer 2 2
Numbness 2 2
Stroke/CVA 2 2
Bacterial Infection 2 2
Erosion 2 2
Fever 2 2
Local Reaction 2 2
Irritation 2 2
Muscular Rigidity 2 2
Necrosis 1 1
Laceration(s) 1 1
Damage to Ligament(s) 1 1
Lupus 1 1
Seroma 1 1
Skin Discoloration 1 1
Erythema 1 1
Hyperplasia 1 1
Ossification 1 1
Organ Dehiscence 1 1
Ambulation Difficulties 1 1
Joint Disorder 1 1
Hypoesthesia 1 1
Arthralgia 1 1
Deformity/ Disfigurement 1 1
Muscle/Tendon Damage 1 1
Osteomyelitis 1 1
Joint Contracture 1 1
Inadequate Osseointegration 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-18-2022
2 Crossroads Extremity Systems Llc II Mar-20-2017
3 In2bones USA, LLC II Dec-22-2018
4 Integra LifeSciences Corp. III Mar-04-2017
5 Merete Medical GmbH II Feb-17-2022
6 Paragon 28, Inc. II Jun-20-2018
7 Stryker GmbH II Nov-16-2020
8 Synthes (USA) Products LLC II Oct-18-2022
9 Synthes (USA) Products LLC II Oct-06-2022
10 TriMed Inc. II Jun-20-2018
11 Wright Medical Technology, Inc. II Mar-31-2022
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