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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 503 503

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3698 3698
Adverse Event Without Identified Device or Use Problem 856 856
Device-Device Incompatibility 422 422
Migration 235 235
Crack 228 228
Detachment of Device or Device Component 227 227
Material Deformation 212 212
Fracture 189 189
Device Dislodged or Dislocated 157 157
Material Separation 121 121
Migration or Expulsion of Device 89 89
Difficult to Advance 87 87
Material Split, Cut or Torn 79 79
Device Damaged Prior to Use 79 79
Material Twisted/Bent 78 78
Premature Activation 69 69
Insufficient Information 67 67
Mechanical Jam 55 55
Entrapment of Device 49 49
Loose or Intermittent Connection 49 49
Patient Device Interaction Problem 45 45
Positioning Failure 44 44
Failure to Advance 38 38
Material Fragmentation 36 36
Patient-Device Incompatibility 34 34
Material Frayed 33 33
Appropriate Term/Code Not Available 33 33
Difficult to Insert 30 30
Unintended Movement 28 28
Defective Device 26 26
Difficult to Remove 25 25
Use of Device Problem 25 25
Physical Resistance/Sticking 22 22
Firing Problem 17 17
Loosening of Implant Not Related to Bone-Ingrowth 17 17
Delivered as Unsterile Product 17 17
Packaging Problem 16 16
Positioning Problem 16 16
Device Contaminated During Manufacture or Shipping 16 16
Manufacturing, Packaging or Shipping Problem 15 15
Activation, Positioning or Separation Problem 12 12
Deformation Due to Compressive Stress 11 11
Component Missing 11 11
Fitting Problem 10 10
Mechanical Problem 10 10
Output Problem 9 9
Biocompatibility 8 8
Device Slipped 8 8
Unsealed Device Packaging 7 7
Disconnection 6 6
Unstable 6 6
Product Quality Problem 6 6
Expulsion 6 6
Contamination /Decontamination Problem 5 5
Device Fell 5 5
Material Rupture 5 5
Peeled/Delaminated 5 5
Flaked 5 5
Nonstandard Device 4 4
Unexpected Therapeutic Results 4 4
Separation Failure 4 4
Device Markings/Labelling Problem 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
Expiration Date Error 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
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
Device Misassembled During Manufacturing /Shipping 2 2
Connection Problem 2 2
Structural Problem 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
Intermittent Program or Algorithm Execution 1 1
Incomplete or Inadequate Connection 1 1
Suction Failure 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3759 3759
No Consequences Or Impact To Patient 894 894
Unspecified Tissue Injury 361 361
Insufficient Information 320 320
Not Applicable 307 307
Foreign Body In Patient 288 288
Unspecified Infection 247 247
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 136 136
No Information 133 133
Device Embedded In Tissue or Plaque 98 98
Inflammation 45 45
Loss of Range of Motion 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Rupture 40 40
Hypersensitivity/Allergic reaction 36 36
Nerve Damage 30 30
Foreign Body Reaction 26 26
Perforation 25 25
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
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
Bone Fracture(s) 5 5
Thrombosis/Thrombus 5 5
Numbness 4 4
Respiratory Failure 3 3
Joint Disorder 3 3
Tissue Breakdown 3 3
Fibrosis 3 3
Autoimmune Disorder 3 3
Edema 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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