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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fastener, fixation, nondegradable, soft tissue
Product CodeMBI
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
ABANZA TECNOMED SL.
  SUBSTANTIALLY EQUIVALENT 1
AEVUMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
AJU PHARM CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHEX, INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 12
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 3
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 6
CAYENNE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CAYENNE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
CAYENNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONEXTIONS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 10
COUSIN BIOTECH S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DUNAMIS LLC
  SUBSTANTIALLY EQUIVALENT 2
FLOWER ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ICONN ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
KATOR LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 10
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 8
MORTISE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-DESIGN (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
OXFORD PERFORMANCE MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC
  SUBSTANTIALLY EQUIVALENT 2
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 4
PARAGON 28,INC.
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
PARCUS MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL LLC.
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 10
RESPONSIVE ARTHROSCOPY LLC
  SUBSTANTIALLY EQUIVALENT 6
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
S.B.M. SAS (SCIENCE & BIO MATERIALS)
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 6
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 2
SUBCHONDRAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD
  SUBSTANTIALLY EQUIVALENT 4
THE ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TIGON MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
U & I CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VALERIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VALERIS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 1
YUNYI (BEIJING) MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 674 674
2018 1072 1072
2019 1303 1303
2020 1453 1453
2021 1891 1891
2022 1279 1279

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2668 2668
Device-Device Incompatibility 751 751
Fracture 495 495
Adverse Event Without Identified Device or Use Problem 442 442
Migration or Expulsion of Device 412 412
Material Separation 360 360
Device Dislodged or Dislocated 270 270
Insufficient Information 233 233
Detachment of Device or Device Component 222 222
Positioning Failure 205 205
Migration 173 173
Mechanical Jam 133 133
Material Fragmentation 117 117
Activation, Positioning or Separation Problem 108 108
Material Split, Cut or Torn 107 107
Material Twisted/Bent 99 99
Physical Resistance/Sticking 96 96
Material Deformation 94 94
Appropriate Term/Code Not Available 85 85
Crack 84 84
Detachment Of Device Component 78 78
Difficult to Insert 73 73
Difficult to Advance 60 60
Failure to Advance 55 55
Loose or Intermittent Connection 53 53
Device Operates Differently Than Expected 52 52
Corroded 51 51
Bent 46 46
Entrapment of Device 42 42
Premature Activation 42 42
Device Slipped 40 40
Material Frayed 39 39
Difficult to Remove 38 38
Firing Problem 35 35
Packaging Problem 33 33
Unintended Movement 33 33
Expulsion 31 31
Positioning Problem 29 29
Component Missing 28 28
Separation Failure 28 28
Use of Device Problem 25 25
Delivered as Unsterile Product 24 24
Expiration Date Error 24 24
Unsealed Device Packaging 23 23
Mechanical Problem 23 23
Failure to Fire 22 22
Device Contaminated During Manufacture or Shipping 21 21
Device Contamination with Chemical or Other Material 19 19
Loosening of Implant Not Related to Bone-Ingrowth 17 17
Device Damaged Prior to Use 17 17
Difficult or Delayed Activation 16 16
Device Markings/Labelling Problem 15 15
Unstable 15 15
Component Falling 14 14
Inaccurate Information 14 14
Activation Problem 13 13
Unraveled Material 12 12
Manufacturing, Packaging or Shipping Problem 12 12
Material Integrity Problem 11 11
Therapeutic or Diagnostic Output Failure 11 11
Patient-Device Incompatibility 11 11
Component Misassembled 10 10
Separation Problem 10 10
Connection Problem 9 9
Malposition of Device 9 9
Difficult to Fold, Unfold or Collapse 9 9
Disassembly 8 8
Contamination /Decontamination Problem 8 8
Deformation Due to Compressive Stress 7 7
Cut In Material 7 7
Device Fell 7 7
Noise, Audible 7 7
Difficult or Delayed Positioning 7 7
Nonstandard Device 7 7
Difficult To Position 7 7
Sticking 7 7
Material Rupture 6 6
Device Expiration Issue 6 6
Misfire 6 6
Tear, Rip or Hole in Device Packaging 6 6
Defective Device 5 5
Patient Device Interaction Problem 5 5
Failure to Eject 5 5
Output Problem 5 5
Degraded 5 5
Disconnection 5 5
Material Disintegration 5 5
Loss of or Failure to Bond 5 5
Device Difficult to Setup or Prepare 5 5
Material Puncture/Hole 5 5
Improper or Incorrect Procedure or Method 5 5
Fitting Problem 5 5
Defective Component 4 4
Shelf Life Exceeded 4 4
Misassembled 4 4
Contamination 4 4
Failure to Discharge 4 4
Material Protrusion/Extrusion 4 4
Mechanics Altered 4 4
Device Handling Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2767 2767
No Known Impact Or Consequence To Patient 1628 1628
No Consequences Or Impact To Patient 991 991
No Information 465 465
Foreign Body In Patient 412 412
Not Applicable 287 287
Insufficient Information 201 201
Device Embedded In Tissue or Plaque 179 179
No Code Available 174 174
Injury 165 165
Pain 143 143
Unspecified Tissue Injury 124 124
Unspecified Infection 88 88
Tissue Damage 83 83
Rupture 66 66
Failure of Implant 66 66
No Patient Involvement 65 65
Loss of Range of Motion 32 32
Swelling/ Edema 30 30
Joint Dislocation 24 24
Bone Fracture(s) 24 24
Osteolysis 23 23
Post Operative Wound Infection 18 18
Scar Tissue 18 18
Cyst(s) 18 18
Swelling 16 16
Hypersensitivity/Allergic reaction 15 15
Inflammation 15 15
Muscle/Tendon Damage 13 13
Perforation 12 12
Damage to Ligament(s) 10 10
Adhesion(s) 10 10
Arthritis 8 8
Hematoma 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Thrombosis/Thrombus 7 7
Joint Laxity 7 7
Reaction 7 7
Irritation 6 6
Erythema 6 6
Patient Problem/Medical Problem 6 6
Fever 5 5
Purulent Discharge 5 5
Wound Dehiscence 5 5
Skin Discoloration 5 5
Nerve Damage 4 4
Excessive Tear Production 4 4
Fibrosis 4 4
Limited Mobility Of The Implanted Joint 3 3
Subluxation 3 3
Fluid Discharge 3 3
Implant Pain 3 3
Discomfort 3 3
Impaired Healing 3 3
Necrosis 3 3
Abscess 3 3
Bacterial Infection 3 3
Fistula 3 3
Foreign Body Reaction 3 3
Muscular Rigidity 3 3
Granuloma 3 3
Incontinence 2 2
Muscle Weakness 2 2
Itching Sensation 2 2
Laceration(s) 2 2
Vessel Or Plaque, Device Embedded In 2 2
Ossification 2 2
Rash 2 2
Local Reaction 2 2
Skin Irritation 2 2
Weakness 2 2
Numbness 2 2
Needle Stick/Puncture 2 2
Non-union Bone Fracture 2 2
Malunion of Bone 2 2
Skin Inflammation/ Irritation 2 2
Subcutaneous Nodule 1 1
Localized Skin Lesion 1 1
Skin Disorders 1 1
Reaction to Medicinal Component of Device 1 1
Hyperesthesia 1 1
Ankylosis 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Fracture, Arm 1 1
Hypoesthesia 1 1
Ulcer 1 1
Discharge 1 1
Prolapse 1 1
Weight Changes 1 1
Closed Capsulotomy 1 1
Sweating 1 1
Burning Sensation 1 1
Urinary Retention 1 1
Vomiting 1 1
Synovitis 1 1
Thrombosis 1 1
Scarring 1 1
Pneumothorax 1 1
Failure to Anastomose 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Jan-11-2019
2 Biomet, Inc. II Dec-17-2020
3 ConMed Corporation II Dec-14-2017
4 OrthoPediatrics Corp II Jul-10-2020
5 Paragon 28, Inc. II Sep-22-2022
6 Smith & Nephew, Inc. II Jul-31-2020
7 Smith & Nephew, Inc. II Apr-22-2020
8 Smith & Nephew, Inc. II Feb-19-2020
9 Stryker Corporation II Mar-02-2020
10 Valeris Medical, LLC II Oct-12-2018
11 Valeris Medical, LLC II Jul-13-2018
12 Zimmer Biomet, Inc. II Sep-26-2018
13 Zimmer Biomet, Inc. II Mar-15-2018
14 Zimmer Biomet, Inc. II Mar-14-2018
15 Zimmer Biomet, Inc. II Mar-01-2018
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