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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
AJU PHARM CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 17
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 11
B-ONE ORTHO, CORP
  SUBSTANTIALLY EQUIVALENT 1
BIORETEC LTD
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CONMED LINVATEC
  SUBSTANTIALLY EQUIVALENT 2
DEPUY MITEK
  SUBSTANTIALLY EQUIVALENT 1
DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY
  SUBSTANTIALLY EQUIVALENT 1
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
  SUBSTANTIALLY EQUIVALENT 15
DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY
  SUBSTANTIALLY EQUIVALENT 2
EMBODY, INC.
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC CORP.
  SUBSTANTIALLY EQUIVALENT 2
LINVATEC CORPORATION D/B/A CONMED LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 8
NANOFIBER SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 3
NANOVA BIOMATERIALS INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOVA BIOMATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 SCIENCE FOR BIO MATERIALS
  SUBSTANTIALLY EQUIVALENT 1
S.B.M. SAS SCIENCES FOR BIO MATERIALS
  SUBSTANTIALLY EQUIVALENT 1
SBM SCIENCES FOR BIO MATERIALS
  SUBSTANTIALLY EQUIVALENT 1
SCIENCE & BIO MATERIALS (S.B.M.) SAS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW ENDOSCOPY, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW INC., ENDOSCOPY DIVISION
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 6
SMITH AND NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH AND NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPORTWELDING GMBH
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL FUSION TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 1
TEKNIMED
  SUBSTANTIALLY EQUIVALENT 1
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIPTEK, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 149 149
2015 182 182
2016 301 301
2017 478 478
2018 1590 1590
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 5419 5419
Adverse Event Without Identified Device or Use Problem 951 951
Device-Device Incompatibility 449 449
Crack 291 291
Detachment of Device or Device Component 263 263
Migration 257 257
Material Deformation 226 226
Fracture 214 214
Device Dislodged or Dislocated 198 198
Migration or Expulsion of Device 186 186
Insufficient Information 151 151
Material Twisted/Bent 134 134
Positioning Failure 128 128
Material Separation 125 125
Activation, Positioning or Separation Problem 116 116
Premature Activation 96 96
Difficult to Advance 94 94
Material Fragmentation 91 91
Material Split, Cut or Torn 91 91
Device Damaged Prior to Use 84 84
Material Frayed 81 81
Mechanical Jam 73 73
Detachment Of Device Component 72 72
Loose or Intermittent Connection 71 71
Appropriate Term/Code Not Available 69 69
Failure to Advance 68 68
Entrapment of Device 62 62
Patient-Device Incompatibility 57 57
Difficult to Insert 51 51
Difficult to Remove 49 49
Patient Device Interaction Problem 48 48
Deformation Due to Compressive Stress 39 39
Defective Device 39 39
Unknown (for use when the device problem is not known) 39 39
Unintended Movement 34 34
Use of Device Problem 33 33
Physical Resistance/Sticking 31 31
Device Operates Differently Than Expected 27 27
Positioning Problem 26 26
Device Slipped 26 26
Mechanical Problem 25 25
Bent 23 23
Loosening of Implant Not Related to Bone-Ingrowth 23 23
Activation Problem 22 22
Device Contaminated During Manufacture or Shipping 19 19
Separation Failure 19 19
Tip breakage 18 18
Delivered as Unsterile Product 17 17
Firing Problem 17 17
Packaging Problem 16 16
Manufacturing, Packaging or Shipping Problem 15 15
Fitting Problem 13 13
Component Missing 12 12
Difficult or Delayed Positioning 12 12
Improper or Incorrect Procedure or Method 11 11
Expulsion 10 10
Failure to Fire 10 10
Material Rupture 10 10
Component Falling 10 10
Loss of or Failure to Bond 10 10
Material Integrity Problem 9 9
Output Problem 9 9
Biocompatibility 8 8
Device Damaged by Another Device 8 8
Failure To Adhere Or Bond 8 8
Nonstandard Device 8 8
Unsealed Device Packaging 8 8
Product Quality Problem 7 7
Device Markings/Labelling Problem 7 7
Material Protrusion/Extrusion 7 7
Unstable 7 7
Split 7 7
Misfire 6 6
Disconnection 6 6
Material Disintegration 6 6
Device Expiration Issue 5 5
Peeled/Delaminated 5 5
Flaked 5 5
Contamination /Decontamination Problem 5 5
Device Fell 5 5
Connection Problem 4 4
Malposition of Device 4 4
Device Contamination with Chemical or Other Material 4 4
Expiration Date Error 4 4
Unexpected Therapeutic Results 4 4
Unraveled Material 4 4
Defective Component 3 3
Microbial Contamination of Device 3 3
Failure to Align 3 3
Device Or Device Fragments Location Unknown 3 3
No Apparent Adverse Event 3 3
Therapeutic or Diagnostic Output Failure 3 3
Sticking 3 3
Hole In Material 3 3
Degraded 3 3
Misassembled During Installation 3 3
Noise, Audible 3 3
Material Too Soft/Flexible 2 2
Component Misassembled 2 2
Program or Algorithm Execution Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3932 3932
No Consequences Or Impact To Patient 2237 2238
No Known Impact Or Consequence To Patient 742 742
Foreign Body In Patient 388 388
Not Applicable 371 371
Unspecified Tissue Injury 366 366
No Code Available 364 364
Insufficient Information 356 356
Unspecified Infection 294 294
Tissue Damage 251 251
Pain 239 240
Injury 221 221
Device Embedded In Tissue or Plaque 196 197
No Information 187 187
Failure of Implant 158 158
Swelling 68 68
Inflammation 64 64
Hypersensitivity/Allergic reaction 54 54
Loss of Range of Motion 48 48
Reaction 48 48
Rupture 44 44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Nerve Damage 35 35
Foreign Body Reaction 33 33
Perforation 29 29
Rash 27 27
Unknown (for use when the patient's condition is not known) 27 27
Swelling/ Edema 25 25
Cyst(s) 22 22
Joint Laxity 18 18
Impaired Healing 18 18
Post Operative Wound Infection 17 17
Osteolysis 17 17
Discomfort 17 17
No Patient Involvement 16 16
Bacterial Infection 15 15
Erythema 15 15
Abscess 14 14
Fever 13 13
Damage to Ligament(s) 13 13
Fluid Discharge 13 13
Surgical procedure, repeated 12 12
Hemorrhage/Bleeding 11 11
Adhesion(s) 11 11
Joint Dislocation 11 11
Bone Fracture(s) 10 10
Scar Tissue 10 10
Synovitis 9 9
Hematoma 9 9
Purulent Discharge 9 9
Edema 9 9
Fatigue 8 8
Burning Sensation 8 8
Itching Sensation 8 8
Staphylococcus Aureus 7 7
Skin Discoloration 7 7
Numbness 7 7
Muscle/Tendon Damage 7 7
Local Reaction 6 6
Laceration(s) 5 5
Wound Dehiscence 5 5
Irritation 5 5
Thrombosis/Thrombus 5 5
Surgical procedure, delayed 5 5
Urticaria 5 5
Complaint, Ill-Defined 4 4
Arthralgia 4 4
Dizziness 4 4
Joint Disorder 4 4
Tissue Breakdown 4 4
Nausea 4 4
Necrosis 4 4
Weakness 4 4
Surgery, prolonged 3 3
Skin Irritation 3 3
Thrombus 3 3
Scarring 3 3
Headache 3 3
Death 3 3
Autoimmune Disorder 3 3
Dyspnea 3 3
Alteration In Body Temperature 3 3
Limited Mobility Of The Implanted Joint 3 3
Fibrosis 3 3
Test Result 3 3
Malaise 3 3
Respiratory Failure 3 3
Surgical procedure, additional 3 3
Ulcer 3 3
Excessive Tear Production 3 3
Discharge 2 2
Joint Swelling 2 2
Anxiety 2 2
Ambulation Difficulties 2 2
Fungal Infection 2 2
Neck Stiffness 2 2
Skin Inflammation 2 2
Patient Problem/Medical Problem 2 2
Weight Changes 2 2
Osteopenia/ Osteoporosis 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Jul-21-2021
2 Arthrex, Inc. II May-05-2017
3 DePuy Mitek, Inc., a Johnson & Johnson Co. II Jun-02-2023
4 DePuy Mitek, Inc., a Johnson & Johnson Co. II Dec-10-2019
5 DePuy Mitek, Inc., a Johnson & Johnson Co. II Mar-06-2012
6 DePuy Mitek, Inc., a Johnson & Johnson Co. II Nov-30-2011
7 Linvatec Corp. dba ConMed Linvatec II Jul-01-2013
8 Smith & Nephew, Inc. II Apr-29-2021
9 Smith & Nephew, Inc. II Oct-21-2020
10 Smith & Nephew, Inc. II Apr-26-2018
11 Smith & Nephew, Inc. II Sep-07-2016
12 Smith & Nephew, Inc. Endoscopy Division II Sep-17-2013
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