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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 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
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
  SUBSTANTIALLY EQUIVALENT 1
RESTORE SURGICAL LLC DBA INSTRATEK
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  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
WRIGHT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 116 116
2018 238 238
2019 242 242
2020 234 234
2021 210 210
2022 178 185

Device Problems MDRs with this Device Problem Events in those MDRs
Break 405 405
Adverse Event Without Identified Device or Use Problem 208 212
Detachment of Device or Device Component 90 90
Fracture 67 67
Material Frayed 37 37
Migration or Expulsion of Device 30 30
Migration 30 33
Appropriate Term/Code Not Available 27 27
Manufacturing, Packaging or Shipping Problem 27 27
Device-Device Incompatibility 26 26
Device Dislodged or Dislocated 25 25
Material Split, Cut or Torn 21 21
Insufficient Information 18 18
Difficult to Advance 18 18
Material Separation 18 18
Loosening of Implant Not Related to Bone-Ingrowth 14 14
Device Operates Differently Than Expected 13 13
Crack 13 13
Physical Resistance/Sticking 10 10
Entrapment of Device 9 9
Activation, Positioning or Separation Problem 9 9
Positioning Failure 8 8
Difficult to Insert 7 7
Detachment Of Device Component 7 7
Patient Device Interaction Problem 7 7
Mechanical Jam 7 7
No Apparent Adverse Event 6 6
Material Deformation 6 6
Improper or Incorrect Procedure or Method 6 6
Failure to Advance 6 6
Patient-Device Incompatibility 5 5
Component Falling 5 5
Difficult to Remove 5 5
Material Twisted/Bent 5 5
Unintended Movement 5 5
Device Contaminated During Manufacture or Shipping 5 5
Packaging Problem 5 5
Activation Problem 4 4
Material Rupture 4 4
Difficult To Position 4 4
Device Slipped 4 4
Mechanical Problem 4 4
Difficult or Delayed Positioning 4 4
Separation Failure 4 4
Failure to Form Staple 3 3
Connection Problem 3 3
Bent 3 3
Corroded 3 3
Loose or Intermittent Connection 3 3
Material Fragmentation 3 3
Delivered as Unsterile Product 3 3
Device Damaged by Another Device 3 3
Therapeutic or Diagnostic Output Failure 2 2
Device Fell 2 2
Failure to Eject 2 2
Firing Problem 2 2
Flaked 2 2
Overheating of Device 2 2
Failure to Align 2 2
Device Markings/Labelling Problem 2 2
Failure to Cut 2 2
Contamination /Decontamination Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Defective Component 2 2
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Loss of Osseointegration 1 1
Fitting Problem 1 1
Misfire 1 1
Defective Device 1 1
Failure to Fire 1 1
Device Operational Issue 1 1
Contamination of Device Ingredient or Reagent 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Expulsion 1 1
Device Contamination with Chemical or Other Material 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
Disassembly 1 1
Material Disintegration 1 1
Unintended Ejection 1 1
Degraded 1 1
Device Difficult to Maintain 1 1
Moisture or Humidity Problem 1 1
Positioning Problem 1 1
Temperature Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 274 274
No Consequences Or Impact To Patient 224 224
No Known Impact Or Consequence To Patient 163 163
No Code Available 91 91
Pain 80 80
Injury 63 63
Non-union Bone Fracture 63 63
Tissue Damage 59 59
Not Applicable 56 56
Failure of Implant 47 47
Foreign Body In Patient 41 41
Unspecified Infection 28 28
Insufficient Information 27 27
No Patient Involvement 24 24
Unspecified Tissue Injury 22 22
No Information 21 21
Loss of Range of Motion 21 24
Bone Fracture(s) 17 17
Post Operative Wound Infection 12 12
Impaired Healing 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Implant Pain 8 12
Reaction 8 8
Wound Dehiscence 7 7
Device Embedded In Tissue or Plaque 6 6
Patient Problem/Medical Problem 5 5
Discomfort 5 5
Abscess 4 4
Cyst(s) 4 4
Hematoma 4 4
Hypersensitivity/Allergic reaction 4 4
Swelling 4 4
Synovitis 3 3
Perforation 3 3
Weakness 3 3
Fall 3 3
Malunion of Bone 3 3
Skin Inflammation/ Irritation 2 2
Physical Asymmetry 2 2
Swelling/ Edema 2 2
Nerve Damage 2 2
Numbness 2 2
Joint Dislocation 2 2
Osteolysis 2 2
Fever 2 2
Foreign Body Reaction 2 2
Arthritis 2 2
Bacterial Infection 2 2
Erosion 2 2
Inflammation 2 2
Irritation 2 2
Local Reaction 2 2
Seroma 1 1
Rupture 1 1
Ulcer 1 1
Hypoesthesia 1 1
Arthralgia 1 1
Deformity/ Disfigurement 1 1
Laceration(s) 1 1
Damage to Ligament(s) 1 1
Lupus 1 1
Muscular Rigidity 1 1
Erythema 1 1
Joint Disorder 1 1
Organ Dehiscence 1 1
Ambulation Difficulties 1 1
Inadequate Osseointegration 1 1
Joint Contracture 1 1
Muscle/Tendon Damage 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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