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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 1
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 740 740

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3814 3814
Adverse Event Without Identified Device or Use Problem 862 862
Device-Device Incompatibility 425 425
Migration 241 241
Detachment of Device or Device Component 238 238
Crack 235 235
Material Deformation 217 217
Fracture 191 191
Device Dislodged or Dislocated 176 176
Material Separation 121 121
Difficult to Advance 91 91
Migration or Expulsion of Device 89 89
Material Twisted/Bent 88 88
Device Damaged Prior to Use 83 83
Material Split, Cut or Torn 81 81
Premature Activation 75 75
Insufficient Information 67 67
Mechanical Jam 55 55
Entrapment of Device 49 49
Loose or Intermittent Connection 49 49
Failure to Advance 47 47
Patient Device Interaction Problem 47 47
Positioning Failure 44 44
Defective Device 39 39
Material Fragmentation 37 37
Material Frayed 34 34
Patient-Device Incompatibility 34 34
Appropriate Term/Code Not Available 33 33
Difficult to Insert 30 30
Unintended Movement 29 29
Physical Resistance/Sticking 29 29
Difficult to Remove 25 25
Use of Device Problem 25 25
Device Contaminated During Manufacture or Shipping 19 19
Loosening of Implant Not Related to Bone-Ingrowth 17 17
Firing Problem 17 17
Delivered as Unsterile Product 17 17
Packaging Problem 16 16
Positioning Problem 16 16
Manufacturing, Packaging or Shipping Problem 15 15
Activation, Positioning or Separation Problem 12 12
Fitting Problem 12 12
Component Missing 11 11
Deformation Due to Compressive Stress 11 11
Mechanical Problem 10 10
Output Problem 9 9
Biocompatibility 8 8
Device Slipped 8 8
Product Quality Problem 7 7
Unsealed Device Packaging 7 7
Disconnection 6 6
Material Rupture 6 6
Unstable 6 6
Device Markings/Labelling Problem 6 6
Expulsion 6 6
Contamination /Decontamination Problem 5 5
Device Fell 5 5
Peeled/Delaminated 5 5
Flaked 5 5
Nonstandard Device 4 4
Unexpected Therapeutic Results 4 4
Expiration Date Error 4 4
Separation Failure 4 4
Material Integrity Problem 4 4
No Apparent Adverse Event 3 3
Misassembled During Installation 3 3
Device Damaged by Another Device 3 3
Failure to Fire 3 3
Improper or Incorrect Procedure or Method 3 3
Unraveled Material 3 3
Degraded 3 3
Difficult or Delayed Positioning 2 2
Component Incompatible 2 2
Misassembled 2 2
Failure to Osseointegrate 2 2
Device Appears to Trigger Rejection 2 2
Defective Component 2 2
Device Contamination with Body Fluid 2 2
Malposition of Device 2 2
Material Too Soft/Flexible 2 2
Component Misassembled 2 2
Program or Algorithm Execution Problem 2 2
Activation Problem 2 2
Scratched Material 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Protrusion/Extrusion 2 2
Connection Problem 2 2
Structural Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Difficult to Open or Remove Packaging Material 1 1
Device Contamination with Chemical or Other Material 1 1
Installation-Related Problem 1 1
Naturally Worn 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Noise, Audible 1 1
Separation Problem 1 1
Premature Separation 1 1
Intermittent Program or Algorithm Execution 1 1
Incomplete or Inadequate Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3931 3931
No Consequences Or Impact To Patient 894 894
Unspecified Tissue Injury 366 366
Insufficient Information 356 356
Not Applicable 307 307
Foreign Body In Patient 302 302
Unspecified Infection 248 248
No Known Impact Or Consequence To Patient 170 170
No Code Available 160 160
Tissue Damage 157 157
Injury 156 156
Pain 144 144
Failure of Implant 137 137
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 28 28
Foreign Body Reaction 26 26
Swelling/ Edema 25 25
Joint Laxity 18 18
No Patient Involvement 16 16
Swelling 16 16
Impaired Healing 14 14
Post Operative Wound Infection 14 14
Reaction 13 13
Abscess 13 13
Damage to Ligament(s) 12 12
Hemorrhage/Bleeding 11 11
Joint Dislocation 11 11
Fluid Discharge 11 11
Adhesion(s) 10 10
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
Discomfort 6 6
Local Reaction 5 5
Synovitis 5 5
Staphylococcus Aureus 5 5
Purulent Discharge 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
Itching Sensation 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
Laceration(s) 2 2
Necrosis 2 2
Bruise/Contusion 2 2
Cellulitis 2 2
Headache 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
Embolism 1 1
Fatigue 1 1
Pulmonary Embolism 1 1
Arthritis 1 1
Paralysis 1 1
Muscle Weakness 1 1
Muscular Rigidity 1 1
Nausea 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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