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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2
EXOTOE LLC
  SUBSTANTIALLY EQUIVALENT 1
F & A FOUNDATION LLC D.B.A. REIGN MEDICAL
  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
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 3
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOVESTMENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28 INC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
TREACE MEDICAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 1
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 239 239
2019 242 242
2020 235 235
2021 210 210
2022 203 210
2023 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Break 390 390
Adverse Event Without Identified Device or Use Problem 210 214
Detachment of Device or Device Component 94 94
Fracture 72 72
Material Frayed 37 37
Migration 31 34
Manufacturing, Packaging or Shipping Problem 29 29
Device-Device Incompatibility 28 28
Device Dislodged or Dislocated 24 24
Material Split, Cut or Torn 23 23
Appropriate Term/Code Not Available 22 22
Migration or Expulsion of Device 19 19
Difficult to Advance 18 18
Material Separation 18 18
Crack 15 15
Loosening of Implant Not Related to Bone-Ingrowth 14 14
Insufficient Information 11 11
Physical Resistance/Sticking 10 10
Entrapment of Device 9 9
Device Operates Differently Than Expected 8 8
Material Deformation 7 7
Patient Device Interaction Problem 7 7
No Apparent Adverse Event 6 6
Mechanical Jam 6 6
Activation, Positioning or Separation Problem 6 6
Device Contaminated During Manufacture or Shipping 5 5
Material Twisted/Bent 5 5
Difficult to Remove 5 5
Failure to Advance 5 5
Patient-Device Incompatibility 5 5
Positioning Failure 5 5
Component Falling 5 5
Mechanical Problem 4 4
Connection Problem 4 4
Unintended Movement 4 4
Activation Problem 4 4
Packaging Problem 3 3
Device Damaged by Another Device 3 3
Failure to Form Staple 3 3
Delivered as Unsterile Product 3 3
Device Slipped 3 3
Corroded 3 3
Detachment Of Device Component 3 3
Material Fragmentation 3 3
Loose or Intermittent Connection 3 3
Flaked 2 2
Difficult to Insert 2 2
Overheating of Device 2 2
Failure to Cut 2 2
Contamination /Decontamination Problem 2 2
Failure to Align 2 2
Separation Failure 2 2
Inadequacy of Device Shape and/or Size 2 2
Defective Component 2 2
Component Missing 2 2
Device Markings/Labelling Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Failure to Eject 2 2
Firing Problem 2 2
Device Fell 2 2
Inaccurate Information 1 1
Device Difficult to Maintain 1 1
Positioning Problem 1 1
Temperature Problem 1 1
Output Problem 1 1
Expulsion 1 1
Device Contamination with Chemical or Other Material 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Tear, Rip or Hole in Device Packaging 1 1
Loss of Osseointegration 1 1
Material Rupture 1 1
Expiration Date Error 1 1
Misfire 1 1
Defective Device 1 1
Off-Label Use 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
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Unintended Ejection 1 1
Material Disintegration 1 1
Degraded 1 1
Difficult or Delayed Positioning 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 316 316
No Consequences Or Impact To Patient 218 218
No Known Impact Or Consequence To Patient 110 110
Pain 79 79
No Code Available 73 73
Injury 60 60
Non-union Bone Fracture 58 58
Tissue Damage 53 53
Not Applicable 51 51
Failure of Implant 47 47
Foreign Body In Patient 36 36
Insufficient Information 30 30
Unspecified Infection 29 29
Loss of Range of Motion 22 25
Unspecified Tissue Injury 22 22
No Patient Involvement 22 22
Bone Fracture(s) 17 17
No Information 16 16
Post Operative Wound Infection 15 15
Impaired Healing 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Implant Pain 8 12
Wound Dehiscence 7 7
Hypersensitivity/Allergic reaction 5 5
Discomfort 5 5
Malunion of Bone 4 4
Hematoma 4 4
Cyst(s) 4 4
Abscess 4 4
Arthritis 3 3
Fall 3 3
Perforation 3 3
Weakness 3 3
Swelling 3 3
Synovitis 3 3
Swelling/ Edema 3 3
Rupture 3 3
Ulcer 2 2
Joint Dislocation 2 2
Physical Asymmetry 2 2
Numbness 2 2
Skin Inflammation/ Irritation 2 2
Nerve Damage 2 2
Fever 2 2
Foreign Body Reaction 2 2
Bacterial Infection 2 2
Erosion 2 2
Inflammation 2 2
Laceration(s) 1 1
Damage to Ligament(s) 1 1
Lupus 1 1
Muscular Rigidity 1 1
Necrosis 1 1
Erythema 1 1
Ossification 1 1
Hyperplasia 1 1
Local Reaction 1 1
Seroma 1 1
Skin Discoloration 1 1
Muscle/Tendon Damage 1 1
Osteomyelitis 1 1
Joint Contracture 1 1
Device Embedded In Tissue or Plaque 1 1
Joint Disorder 1 1
Hypoesthesia 1 1
Deformity/ Disfigurement 1 1
Reaction 1 1
Organ Dehiscence 1 1
Ambulation Difficulties 1 1
Inadequate Osseointegration 1 1
Patient Problem/Medical Problem 1 1

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