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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fastener, fixation, biodegradable, soft tissue
Product CodeMAI
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ACUITIVE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ACUITIVE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 12
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
B-ONE ORTHO, CORP
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DEPUY MITEK
  SUBSTANTIALLY EQUIVALENT 1
EMBODY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 2
NANOFIBER SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 3
OSSIO LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
PARCUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
SCIENCE & BIO MATERIALS (S.B.M.) SAS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL FUSION TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 1
TEKNIMED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1247 1247
2020 957 957
2021 1267 1267
2022 1432 1432
2023 1720 1720
2024 1239 1239

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4055 4055
Adverse Event Without Identified Device or Use Problem 870 870
Device-Device Incompatibility 442 442
Detachment of Device or Device Component 258 258
Migration 256 256
Crack 250 250
Material Deformation 233 233
Device Dislodged or Dislocated 202 202
Fracture 193 193
Material Separation 124 124
Difficult to Advance 113 113
Premature Activation 96 96
Material Twisted/Bent 95 95
Device Damaged Prior to Use 90 90
Migration or Expulsion of Device 89 89
Material Split, Cut or Torn 88 88
Insufficient Information 67 67
Failure to Advance 60 60
Mechanical Jam 59 59
Patient Device Interaction Problem 54 54
Positioning Failure 54 54
Defective Device 51 51
Entrapment of Device 49 49
Loose or Intermittent Connection 49 49
Unintended Movement 39 39
Material Frayed 38 38
Material Fragmentation 37 37
Appropriate Term/Code Not Available 36 36
Physical Resistance/Sticking 36 36
Patient-Device Incompatibility 34 34
Difficult to Insert 32 32
Use of Device Problem 29 29
Difficult to Remove 25 25
Device Contaminated During Manufacture or Shipping 20 20
Loosening of Implant Not Related to Bone-Ingrowth 18 18
Firing Problem 17 17
Manufacturing, Packaging or Shipping Problem 17 17
Delivered as Unsterile Product 17 17
Packaging Problem 16 16
Positioning Problem 16 16
Activation, Positioning or Separation Problem 12 12
Fitting Problem 12 12
Component Missing 12 12
Mechanical Problem 11 11
Deformation Due to Compressive Stress 11 11
Output Problem 9 9
Biocompatibility 8 8
Unsealed Device Packaging 8 8
Product Quality Problem 8 8
Device Slipped 8 8
Unstable 7 7
Material Rupture 6 6
Flaked 6 6
Disconnection 6 6
Device Markings/Labelling Problem 6 6
Expulsion 6 6
Device Damaged by Another Device 5 5
Contamination /Decontamination Problem 5 5
Device Fell 5 5
Separation Problem 5 5
Peeled/Delaminated 5 5
Nonstandard Device 4 4
Unexpected Therapeutic Results 4 4
Unraveled Material 4 4
Failure to Fire 4 4
Separation Failure 4 4
Expiration Date Error 4 4
Component Misassembled 4 4
Material Integrity Problem 4 4
No Apparent Adverse Event 3 3
Misassembled During Installation 3 3
Improper or Incorrect Procedure or Method 3 3
Melted 3 3
Degraded 3 3
Difficult or Delayed Positioning 3 3
Component Incompatible 2 2
Misassembled 2 2
Defective Component 2 2
Device Contamination with Body Fluid 2 2
Loss of Osseointegration 2 2
Structural Problem 2 2
Malposition of Device 2 2
Failure to Osseointegrate 2 2
Device Appears to Trigger Rejection 2 2
Missing Information 2 2
Material Too Soft/Flexible 2 2
Activation Problem 2 2
Program or Algorithm Execution Problem 2 2
Scratched Material 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Protrusion/Extrusion 2 2
Connection Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Failure to Auto Stop 1 1
Device Contamination with Chemical or Other Material 1 1
Installation-Related Problem 1 1
Difficult to Open or Close 1 1
Difficult to Open or Remove Packaging Material 1 1
Naturally Worn 1 1
Environmental Particulates 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4330 4330
No Consequences Or Impact To Patient 894 894
Insufficient Information 430 430
Unspecified Tissue Injury 369 369
Foreign Body In Patient 315 315
Not Applicable 307 307
Unspecified Infection 256 256
No Known Impact Or Consequence To Patient 170 170
No Code Available 160 160
Tissue Damage 157 157
Injury 156 156
Failure of Implant 145 145
Pain 144 144
No Information 133 133
Device Embedded In Tissue or Plaque 100 100
Inflammation 46 46
Loss of Range of Motion 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Rupture 40 40
Hypersensitivity/Allergic reaction 38 38
Nerve Damage 32 32
Perforation 32 32
Foreign Body Reaction 30 30
Swelling/ Edema 25 25
Joint Laxity 19 19
No Patient Involvement 16 16
Impaired Healing 16 16
Swelling 16 16
Post Operative Wound Infection 14 14
Reaction 13 13
Abscess 13 13
Damage to Ligament(s) 13 13
Fluid Discharge 12 12
Joint Dislocation 11 11
Hemorrhage/Bleeding 11 11
Adhesion(s) 11 11
Rash 10 10
Scar Tissue 10 10
Fever 9 9
Hematoma 9 9
Erythema 8 8
Cyst(s) 8 8
Bone Fracture(s) 7 7
Muscle/Tendon Damage 7 7
Osteolysis 6 6
Bacterial Infection 6 6
Local Reaction 6 6
Discomfort 6 6
Synovitis 5 5
Staphylococcus Aureus 5 5
Purulent Discharge 5 5
Itching Sensation 5 5
Thrombosis/Thrombus 5 5
Numbness 4 4
Respiratory Failure 3 3
Joint Disorder 3 3
Tissue Breakdown 3 3
Fibrosis 3 3
Edema 3 3
Autoimmune Disorder 3 3
Death 3 3
Wound Dehiscence 3 3
Thrombus 3 3
Skin Discoloration 2 2
Renal Failure 2 2
Arthralgia 2 2
Ulcer 2 2
Urticaria 2 2
Weakness 2 2
Burning Sensation 2 2
Bruise/Contusion 2 2
Cellulitis 2 2
Headache 2 2
Laceration(s) 2 2
Necrosis 2 2
Osteopenia/ Osteoporosis 2 2
Osteomyelitis 2 2
Localized Skin Lesion 2 2
Reaction to Medicinal Component of Device 2 2
Skin Infection 2 2
Drug Resistant Bacterial Infection 1 1
Ankylosis 1 1
Implant Pain 1 1
Skin Disorders 1 1
Subluxation 1 1
Limited Mobility Of The Implanted Joint 1 1
Patient Problem/Medical Problem 1 1
Skin Tears 1 1
Neck Stiffness 1 1
Skin Inflammation 1 1
Paralysis 1 1
Muscle Weakness 1 1
Muscular Rigidity 1 1
Nausea 1 1
Embolism 1 1
Fatigue 1 1
Pulmonary Embolism 1 1
Arthritis 1 1
Cramp(s) 1 1
Dizziness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Jul-21-2021
2 DePuy Mitek, Inc., a Johnson & Johnson Co. II Jun-02-2023
3 DePuy Mitek, Inc., a Johnson & Johnson Co. II Dec-10-2019
4 Smith & Nephew, Inc. II Apr-29-2021
5 Smith & Nephew, Inc. II Oct-21-2020
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