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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 16
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
B-ONE ORTHO, CORP
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EMBODY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 5
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
S.B.M. SAS SCIENCES FOR BIO MATERIALS
  SUBSTANTIALLY EQUIVALENT 1
SCIENCE & BIO MATERIALS (S.B.M.) SAS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH AND NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH AND NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPORTWELDING GMBH
  SUBSTANTIALLY EQUIVALENT 1
TEKNIMED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1590 1590
2019 1247 1247
2020 957 957
2021 1267 1267
2022 1432 1432
2023 1337 1337

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4175 4175
Adverse Event Without Identified Device or Use Problem 867 867
Device-Device Incompatibility 419 419
Crack 246 246
Migration 218 218
Detachment of Device or Device Component 201 201
Fracture 187 187
Material Deformation 185 185
Migration or Expulsion of Device 161 161
Positioning Failure 124 124
Material Separation 120 120
Material Twisted/Bent 118 118
Device Dislodged or Dislocated 111 111
Material Split, Cut or Torn 87 87
Material Frayed 77 77
Difficult to Advance 74 74
Device Damaged Prior to Use 73 73
Mechanical Jam 67 67
Insufficient Information 62 62
Loose or Intermittent Connection 57 57
Entrapment of Device 56 56
Activation, Positioning or Separation Problem 53 53
Premature Activation 50 50
Failure to Advance 47 47
Material Fragmentation 43 43
Patient-Device Incompatibility 40 40
Deformation Due to Compressive Stress 39 39
Appropriate Term/Code Not Available 37 37
Patient Device Interaction Problem 35 35
Difficult to Insert 32 32
Difficult to Remove 27 27
Unintended Movement 27 27
Mechanical Problem 24 24
Positioning Problem 23 23
Loosening of Implant Not Related to Bone-Ingrowth 23 23
Defective Device 19 19
Physical Resistance/Sticking 18 18
Firing Problem 17 17
Delivered as Unsterile Product 17 17
Use of Device Problem 17 17
Packaging Problem 15 15
Manufacturing, Packaging or Shipping Problem 15 15
Device Contaminated During Manufacture or Shipping 13 13
Device Slipped 12 12
Detachment Of Device Component 12 12
Component Missing 11 11
Separation Failure 11 11
Failure to Fire 10 10
Loss of or Failure to Bond 10 10
Bent 9 9
Output Problem 9 9
Device Damaged by Another Device 7 7
Activation Problem 7 7
Unsealed Device Packaging 7 7
Material Rupture 7 7
Product Quality Problem 6 6
Unstable 6 6
Disconnection 6 6
Fitting Problem 6 6
Misfire 6 6
Expulsion 6 6
Material Integrity Problem 5 5
Device Fell 5 5
Peeled/Delaminated 5 5
Flaked 5 5
Improper or Incorrect Procedure or Method 4 4
Unexpected Therapeutic Results 4 4
Device Operates Differently Than Expected 4 4
Device Markings/Labelling Problem 4 4
Contamination /Decontamination Problem 3 3
No Apparent Adverse Event 3 3
Unraveled Material 3 3
Nonstandard Device 3 3
Expiration Date Error 3 3
Material Disintegration 3 3
Degraded 3 3
Difficult or Delayed Positioning 3 3
Failure To Adhere Or Bond 3 3
Component Incompatible 2 2
Material Invagination 2 2
Structural Problem 2 2
Device Contamination with Body Fluid 2 2
Failure to Osseointegrate 2 2
Defective Component 2 2
Device Appears to Trigger Rejection 2 2
Misassembled 2 2
Scratched Material 2 2
Therapeutic or Diagnostic Output Failure 2 2
Component Misassembled 2 2
Noise, Audible 2 2
Material Too Soft/Flexible 2 2
Program or Algorithm Execution Problem 2 2
Suction Failure 2 2
Separation Problem 2 2
Connection Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Malposition of Device 2 2
Biocompatibility 2 2
Device Contamination with Chemical or Other Material 2 2
Installation-Related Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3049 3049
No Consequences Or Impact To Patient 2126 2126
No Known Impact Or Consequence To Patient 379 379
Not Applicable 368 368
Unspecified Tissue Injury 346 346
Foreign Body In Patient 308 308
Unspecified Infection 238 238
Insufficient Information 235 235
Injury 191 191
Tissue Damage 191 191
No Code Available 174 174
Pain 162 163
Failure of Implant 137 137
No Information 134 134
Device Embedded In Tissue or Plaque 103 103
Inflammation 44 44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Loss of Range of Motion 41 41
Rupture 41 41
Hypersensitivity/Allergic reaction 35 35
Nerve Damage 31 31
Foreign Body Reaction 29 29
Swelling 25 25
Swelling/ Edema 25 25
Reaction 21 21
Joint Laxity 18 18
Post Operative Wound Infection 16 16
No Patient Involvement 16 16
Impaired Healing 14 14
Rash 13 13
Perforation 13 13
Damage to Ligament(s) 12 12
Cyst(s) 12 12
Fluid Discharge 12 12
Joint Dislocation 11 11
Fever 11 11
Hemorrhage/Bleeding 11 11
Adhesion(s) 10 10
Bacterial Infection 10 10
Scar Tissue 10 10
Erythema 9 9
Hematoma 9 9
Abscess 8 8
Numbness 7 7
Muscle/Tendon Damage 7 7
Discomfort 6 6
Bone Fracture(s) 6 6
Purulent Discharge 5 5
Staphylococcus Aureus 5 5
Local Reaction 5 5
Synovitis 5 5
Nausea 4 4
Edema 4 4
Wound Dehiscence 4 4
Fatigue 4 4
Itching Sensation 4 4
Arthralgia 4 4
Dizziness 4 4
Thrombosis/Thrombus 4 4
Urticaria 3 3
Joint Disorder 3 3
Osteolysis 3 3
Respiratory Failure 3 3
Fibrosis 3 3
Tissue Breakdown 3 3
Headache 3 3
Autoimmune Disorder 3 3
Death 3 3
Thrombus 3 3
Skin Discoloration 3 3
Weakness 3 3
Burning Sensation 3 3
Renal Failure 2 2
Cellulitis 2 2
Laceration(s) 2 2
Muscle Spasm(s) 2 2
Patient Problem/Medical Problem 2 2
Weight Changes 2 2
Limited Mobility Of The Implanted Joint 2 2
Neck Stiffness 2 2
Anxiety 2 2
Ulcer 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
Implant Pain 1 1
Skin Disorders 1 1
Subluxation 1 1
Ankylosis 1 1
Hypoesthesia 1 1
Skin Inflammation 1 1
Sweating 1 1
Osteopenia/ Osteoporosis 1 1
Skin Tears 1 1
Ambulation Difficulties 1 1
Alteration In Body Temperature 1 1
Muscle Weakness 1 1
Muscular Rigidity 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
6 Smith & Nephew, Inc. II Apr-26-2018
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