• 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
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 12
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
B-ONE ORTHO, CORP
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DEPUY MITEK
  SUBSTANTIALLY EQUIVALENT 2
EMBODY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 2
NANOFIBER SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 4
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 1946 1946

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4480 4480
Adverse Event Without Identified Device or Use Problem 918 918
Device-Device Incompatibility 473 473
Migration 288 288
Detachment of Device or Device Component 283 283
Crack 265 265
Material Deformation 264 264
Device Dislodged or Dislocated 227 227
Fracture 200 200
Difficult to Advance 135 135
Material Separation 124 124
Premature Activation 124 124
Material Twisted/Bent 98 98
Device Damaged Prior to Use 94 94
Material Split, Cut or Torn 90 90
Migration or Expulsion of Device 89 89
Positioning Failure 71 71
Insufficient Information 68 68
Failure to Advance 66 66
Mechanical Jam 64 64
Patient Device Interaction Problem 63 63
Defective Device 53 53
Entrapment of Device 49 49
Loose or Intermittent Connection 49 49
Unintended Movement 42 42
Material Frayed 40 40
Appropriate Term/Code Not Available 40 40
Physical Resistance/Sticking 40 40
Material Fragmentation 38 38
Use of Device Problem 35 35
Patient-Device Incompatibility 34 34
Difficult to Insert 33 33
Difficult to Remove 25 25
Loosening of Implant Not Related to Bone-Ingrowth 20 20
Device Contaminated During Manufacture or Shipping 20 20
Firing Problem 17 17
Delivered as Unsterile Product 17 17
Packaging Problem 17 17
Manufacturing, Packaging or Shipping Problem 17 17
Positioning Problem 16 16
Component Missing 13 13
Fitting Problem 13 13
Activation, Positioning or Separation Problem 12 12
Deformation Due to Compressive Stress 11 11
Mechanical Problem 11 11
Output Problem 9 9
Product Quality Problem 8 8
Unsealed Device Packaging 8 8
Biocompatibility 8 8
Device Slipped 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4895 4895
No Consequences Or Impact To Patient 894 894
Insufficient Information 514 514
Unspecified Tissue Injury 398 398
Foreign Body In Patient 343 343
Not Applicable 307 307
Unspecified Infection 266 266
No Known Impact Or Consequence To Patient 170 170
No Code Available 160 160
Failure of Implant 159 159
Tissue Damage 157 157
Injury 156 156
Pain 148 148
No Information 133 133
Device Embedded In Tissue or Plaque 106 106
Inflammation 47 47
Perforation 44 44
Loss of Range of Motion 42 42
Hypersensitivity/Allergic reaction 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Rupture 41 41
Nerve Damage 34 34
Foreign Body Reaction 34 34
Swelling/ Edema 32 32
Joint Laxity 21 21
Impaired Healing 18 18
No Patient Involvement 16 16
Swelling 16 16
Post Operative Wound Infection 15 15
Damage to Ligament(s) 14 14
Abscess 13 13
Reaction 13 13
Fluid Discharge 13 13
Adhesion(s) 11 11
Hemorrhage/Bleeding 11 11
Joint Dislocation 11 11
Rash 10 10
Scar Tissue 10 10
Synovitis 9 9
Discomfort 9 9
Hematoma 9 9
Fever 9 9
Erythema 8 8
Cyst(s) 8 8
Sepsis 8 8
Bone Fracture(s) 7 7
Muscle/Tendon Damage 7 7
Bacterial Infection 6 6
Local Reaction 6 6
Osteolysis 6 6

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
-
-