Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 1005 1005

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5546 5546
Adverse Event Without Identified Device or Use Problem 953 953
Device-Device Incompatibility 455 455
Crack 297 297
Detachment of Device or Device Component 275 275
Migration 263 263
Material Deformation 232 232
Fracture 216 216
Device Dislodged or Dislocated 209 209
Migration or Expulsion of Device 186 186
Insufficient Information 151 151
Material Twisted/Bent 140 140
Positioning Failure 132 132
Material Separation 125 125
Activation, Positioning or Separation Problem 116 116
Premature Activation 111 111
Difficult to Advance 109 109
Material Split, Cut or Torn 96 96
Material Fragmentation 91 91
Device Damaged Prior to Use 87 87
Material Frayed 85 85
Mechanical Jam 75 75
Failure to Advance 74 74
Detachment Of Device Component 72 72
Loose or Intermittent Connection 71 71
Appropriate Term/Code Not Available 70 70
Entrapment of Device 62 62
Patient-Device Incompatibility 57 57
Difficult to Insert 52 52
Defective Device 49 49
Difficult to Remove 49 49
Patient Device Interaction Problem 48 48
Unintended Movement 41 41
Unknown (for use when the device problem is not known) 39 39
Deformation Due to Compressive Stress 39 39
Use of Device Problem 35 35
Physical Resistance/Sticking 33 33
Device Operates Differently Than Expected 27 27
Device Slipped 26 26
Mechanical Problem 26 26
Positioning Problem 26 26
Loosening of Implant Not Related to Bone-Ingrowth 24 24
Bent 23 23
Activation Problem 22 22
Separation Failure 19 19
Device Contaminated During Manufacture or Shipping 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
Difficult or Delayed Positioning 13 13
Component Missing 13 13
Improper or Incorrect Procedure or Method 11 11
Failure to Fire 10 10
Loss of or Failure to Bond 10 10
Expulsion 10 10
Component Falling 10 10
Material Rupture 10 10
Output Problem 9 9
Device Damaged by Another Device 9 9
Unsealed Device Packaging 9 9
Material Integrity Problem 9 9
Unstable 8 8
Failure To Adhere Or Bond 8 8
Product Quality Problem 8 8
Nonstandard Device 8 8
Biocompatibility 8 8
Device Markings/Labelling Problem 7 7
Split 7 7
Material Protrusion/Extrusion 7 7
Disconnection 6 6
Material Disintegration 6 6
Misfire 6 6
Unraveled Material 5 5
Contamination /Decontamination Problem 5 5
Device Fell 5 5
Flaked 5 5
Device Expiration Issue 5 5
Peeled/Delaminated 5 5
Device Contamination with Chemical or Other Material 4 4
Malposition of Device 4 4
Unexpected Therapeutic Results 4 4
Expiration Date Error 4 4
Connection Problem 4 4
Component Misassembled 3 3
No Apparent Adverse Event 3 3
Therapeutic or Diagnostic Output Failure 3 3
Degraded 3 3
Misassembled During Installation 3 3
Defective Component 3 3
Device Or Device Fragments Location Unknown 3 3
Microbial Contamination of Device 3 3
Failure to Align 3 3
Separation Problem 3 3
Noise, Audible 3 3
Sticking 3 3
Hole In Material 3 3
Component Incompatible 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4142 4142
No Consequences Or Impact To Patient 2237 2238
No Known Impact Or Consequence To Patient 742 742
Insufficient Information 399 399
Foreign Body In Patient 395 395
Not Applicable 371 371
Unspecified Tissue Injury 368 368
No Code Available 364 364
Unspecified Infection 295 295
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 159 159
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 32 32
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 19 19
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
Adhesion(s) 12 12
Surgical procedure, repeated 12 12
Hemorrhage/Bleeding 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
-
-