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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
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 2
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 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Break 310 310
Adverse Event Without Identified Device or Use Problem 234 238
Detachment of Device or Device Component 122 122
Fracture 73 73
Device-Device Incompatibility 29 29
Device Dislodged or Dislocated 29 29
Manufacturing, Packaging or Shipping Problem 29 29
Migration 29 32
Difficult to Advance 21 21
Material Split, Cut or Torn 19 19
Appropriate Term/Code Not Available 17 17
Material Separation 17 17
Migration or Expulsion of Device 16 16
Physical Resistance/Sticking 16 16
Loosening of Implant Not Related to Bone-Ingrowth 15 15
Crack 13 13
Insufficient Information 10 10
Entrapment of Device 9 9
Material Frayed 9 9
Patient Device Interaction Problem 8 8
Material Deformation 8 8
No Apparent Adverse Event 6 6
Unintended Movement 5 5
Material Twisted/Bent 5 5
Difficult to Remove 5 5
Loose or Intermittent Connection 4 4
Mechanical Problem 4 4
Mechanical Jam 4 4
Failure to Advance 4 4
Patient-Device Incompatibility 4 4
Activation Problem 4 4
Inaccurate Information 4 4
Device Damaged by Another Device 3 3
Packaging Problem 3 3
Corroded 3 3
Delivered as Unsterile Product 3 3
Flaked 2 2
Defective Component 2 2
Component Missing 2 2
Inadequacy of Device Shape and/or Size 2 2
Difficult or Delayed Positioning 2 2
Positioning Failure 2 2
Material Fragmentation 2 2
Device Contaminated During Manufacture or Shipping 2 2
Therapeutic or Diagnostic Output Failure 2 2
Failure to Align 2 2
Connection Problem 2 2
Activation, Positioning or Separation Problem 2 2
Failure to Form Staple 2 2
Failure to Cut 2 2
Failure to Eject 2 2
Firing Problem 2 2
Defective Device 1 1
Expiration Date Error 1 1
Contamination /Decontamination Problem 1 1
Device Markings/Labelling Problem 1 1
Expulsion 1 1
Device Difficult to Maintain 1 1
Positioning Problem 1 1
Output Problem 1 1
Material Integrity Problem 1 1
Difficult to Insert 1 1
Melted 1 1
Nonstandard Device 1 1
Material Disintegration 1 1
Unintended Ejection 1 1
Degraded 1 1
Device Slipped 1 1
Stretched 1 1
Unstable 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Loss of Osseointegration 1 1
Output above Specifications 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 404 404
No Consequences Or Impact To Patient 104 104
Pain 78 78
No Code Available 59 59
Injury 55 55
Non-union Bone Fracture 53 53
Tissue Damage 48 48
Not Applicable 45 45
Insufficient Information 44 44
Failure of Implant 44 44
No Known Impact Or Consequence To Patient 41 41
Foreign Body In Patient 33 33
Unspecified Infection 28 28
Unspecified Tissue Injury 23 23
Loss of Range of Motion 21 24
No Patient Involvement 19 19
Post Operative Wound Infection 17 17
Bone Fracture(s) 17 17
No Information 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Impaired Healing 11 11
Discomfort 10 10
Perforation 10 10
Implant Pain 9 13
Wound Dehiscence 8 8
Hypersensitivity/Allergic reaction 6 6
Foreign Body Reaction 5 5
Hematoma 4 4
Cyst(s) 4 4
Fall 4 4
Abscess 4 4
Rupture 4 4
Malunion of Bone 4 4
Device Embedded In Tissue or Plaque 3 3
Swelling/ Edema 3 3
Osteolysis 3 3
Synovitis 3 3
Arthritis 3 3
Cellulitis 3 3
Stroke/CVA 2 2
Bacterial Infection 2 2
Erosion 2 2
Fever 2 2
Swelling 2 2
Ulcer 2 2
Muscular Rigidity 2 2
Inflammation 2 2
Numbness 2 2
Joint Dislocation 2 2
Skin Inflammation/ Irritation 2 2
Physical Asymmetry 2 2
Muscle/Tendon Damage 1 1
Osteomyelitis 1 1
Joint Contracture 1 1
Reaction 1 1
Joint Disorder 1 1
Hypoesthesia 1 1
Deformity/ Disfigurement 1 1
Organ Dehiscence 1 1
Ambulation Difficulties 1 1
Inadequate Osseointegration 1 1
Patient Problem/Medical Problem 1 1
Laceration(s) 1 1
Damage to Ligament(s) 1 1
Lupus 1 1
Necrosis 1 1
Nerve Damage 1 1
Weakness 1 1
Seroma 1 1
Skin Discoloration 1 1
Erythema 1 1
Hyperplasia 1 1
Ossification 1 1

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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