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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
ACUITIVE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AEVUMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AJU PHARM CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANIKA THERAPEUTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 17
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 4
BAAT MEDICAL PRODUCTS B.V.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 5
CAYENNE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CONEXTIONS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
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
GM DOS REIS INDUSTRIA E COMERICO LTDA
  SUBSTANTIALLY EQUIVALENT 1
HEALTHIUM MEDTECH LIMITED
  SUBSTANTIALLY EQUIVALENT 5
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INTEGRITY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
JARMON MEDICAL, LLC (DBA LEGENDS ORTHOPEDICS)
  SUBSTANTIALLY EQUIVALENT 1
MARUHO MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 4
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 9
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 9
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-DESIGN (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
OTS MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
OXFORD PERFORMANCE MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC
  SUBSTANTIALLY EQUIVALENT 2
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 7
PARAGON 28,INC.
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL LLC.
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 10
RESPONSIVE ARTHROSCOPY LLC
  SUBSTANTIALLY EQUIVALENT 8
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 8
RIVERPOINT MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 4
S.B.M. SAS (SCIENCE & BIO MATERIALS)
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
SIMPARO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 6
SUBCHONDRAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU ENDOPHIX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD
  SUBSTANTIALLY EQUIVALENT 4
TIGON MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
VALERIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VALERIS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 1
YUNYI (BEIJING) MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1303 1303
2020 1453 1453
2021 1890 1890
2022 1586 1586
2023 2506 2506
2024 2220 2220

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3728 3728
Device-Device Incompatibility 1162 1162
Device Dislodged or Dislocated 702 702
Adverse Event Without Identified Device or Use Problem 700 700
Fracture 680 680
Detachment of Device or Device Component 397 397
Material Separation 355 355
Migration 274 274
Migration or Expulsion of Device 272 272
Material Split, Cut or Torn 259 259
Physical Resistance/Sticking 241 241
Insufficient Information 212 212
Positioning Failure 178 178
Difficult to Advance 177 177
Material Twisted/Bent 173 173
Failure to Advance 167 167
Material Deformation 156 156
Mechanical Jam 142 142
Material Fragmentation 141 141
Crack 112 112
Defective Device 110 110
Premature Activation 99 99
Unintended Movement 89 89
Appropriate Term/Code Not Available 81 81
Use of Device Problem 75 75
Expiration Date Error 70 70
Packaging Problem 69 69
Material Frayed 60 60
Patient Device Interaction Problem 59 59
Difficult to Insert 57 57
Corroded 51 51
Delivered as Unsterile Product 49 49
Separation Failure 44 44
Difficult or Delayed Activation 43 43
Failure to Fire 43 43
Activation, Positioning or Separation Problem 43 43
Fitting Problem 42 42
Entrapment of Device 40 40
Firing Problem 38 38
Loose or Intermittent Connection 33 33
Mechanical Problem 29 29
Device Slipped 29 29
Difficult to Remove 28 28
Device Damaged Prior to Use 28 28
Component Missing 27 27
Device Contaminated During Manufacture or Shipping 23 23
Expulsion 22 22
Unsealed Device Packaging 21 21
Unstable 19 19
Loosening of Implant Not Related to Bone-Ingrowth 19 19
Positioning Problem 17 17
Premature Separation 16 16
Manufacturing, Packaging or Shipping Problem 15 15
Inaccurate Information 14 14
Activation Problem 14 14
Component Misassembled 13 13
Noise, Audible 13 13
Material Integrity Problem 13 13
Output Problem 13 13
Improper or Incorrect Procedure or Method 13 13
Patient-Device Incompatibility 12 12
Tear, Rip or Hole in Device Packaging 11 11
Material Rupture 11 11
Therapeutic or Diagnostic Output Failure 11 11
Deformation Due to Compressive Stress 10 10
Separation Problem 10 10
Connection Problem 9 9
Activation Failure 9 9
Difficult to Fold, Unfold or Collapse 9 9
Nonstandard Device 8 8
Defective Component 8 8
Failure to Eject 8 8
Device Markings/Labelling Problem 7 7
Inadequacy of Device Shape and/or Size 7 7
Contamination 7 7
Degraded 6 6
Difficult or Delayed Positioning 6 6
Product Quality Problem 6 6
Malposition of Device 6 6
Contamination /Decontamination Problem 6 6
No Apparent Adverse Event 6 6
Device Fell 6 6
Device Damaged by Another Device 5 5
Disconnection 5 5
Material Disintegration 4 4
Failure to Discharge 4 4
Misfire 4 4
Device Handling Problem 4 4
Ejection Problem 4 4
Device Misassembled During Manufacturing /Shipping 3 3
Failure to Disconnect 3 3
Retraction Problem 3 3
Unexpected Therapeutic Results 3 3
Unraveled Material 3 3
Off-Label Use 3 3
Material Puncture/Hole 3 3
Peeled/Delaminated 2 2
Device Difficult to Setup or Prepare 2 2
Misassembled 2 2
Misconnection 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6340 6340
Insufficient Information 878 878
No Known Impact Or Consequence To Patient 770 770
Foreign Body In Patient 641 641
No Consequences Or Impact To Patient 587 587
No Information 348 348
Not Applicable 240 240
Failure of Implant 184 184
Unspecified Tissue Injury 179 179
Pain 160 160
Injury 156 156
Device Embedded In Tissue or Plaque 140 140
Rupture 132 132
Perforation 125 125
Unspecified Infection 111 111
No Code Available 100 100
Loss of Range of Motion 61 61
Damage to Ligament(s) 49 49
No Patient Involvement 47 47
Swelling/ Edema 36 36
Hypersensitivity/Allergic reaction 31 31
Joint Dislocation 31 31
Muscle/Tendon Damage 27 27
Osteolysis 25 25
Post Operative Wound Infection 25 25
Scar Tissue 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Tissue Damage 23 23
Bone Fracture(s) 18 18
Inflammation 18 18
Joint Laxity 16 16
Adhesion(s) 15 15
Swelling 14 14
Fibrosis 14 14
Hematoma 13 13
Muscular Rigidity 10 10
Ossification 10 10
Cyst(s) 10 10
Foreign Body Reaction 9 9
Skin Inflammation/ Irritation 9 9
Thrombosis/Thrombus 8 8
Erythema 8 8
Wound Dehiscence 8 8
Arthritis 8 8
Fever 7 7
Synovitis 7 7
Nerve Damage 7 7
Impaired Healing 7 7
Laceration(s) 6 6
Irritation 6 6
Patient Problem/Medical Problem 6 6
Non-union Bone Fracture 5 5
Subcutaneous Nodule 5 5
Purulent Discharge 5 5
Bacterial Infection 5 5
Discomfort 5 5
Skin Discoloration 5 5
Neuropathy 4 4
Numbness 4 4
Implant Pain 4 4
Fluid Discharge 4 4
Subluxation 4 4
Alteration in Body Temperature 3 3
Nodule 3 3
Malunion of Bone 3 3
Skin Infection 3 3
Reaction 3 3
Excessive Tear Production 3 3
Abscess 3 3
Fistula 3 3
Necrosis 3 3
Incontinence 2 2
Granuloma 2 2
Bruise/Contusion 2 2
Ulcer 2 2
Pneumothorax 2 2
Local Reaction 2 2
Fungal Infection 2 2
Irritability 2 2
Skin Disorders 2 2
Osteomyelitis 2 2
Unspecified Musculoskeletal problem 1 1
Blister 1 1
Localized Skin Lesion 1 1
Solid Tumour 1 1
Reaction to Medicinal Component of Device 1 1
Ankylosis 1 1
Joint Contracture 1 1
Hyperesthesia 1 1
Paresthesia 1 1
Limited Mobility Of The Implanted Joint 1 1
Tissue Breakdown 1 1
Fracture, Arm 1 1
Hypoesthesia 1 1
Needle Stick/Puncture 1 1
Prolapse 1 1
Closed Capsulotomy 1 1
Weakness 1 1
Burning Sensation 1 1
Renal Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Jan-11-2019
2 Biomet, Inc. II Dec-17-2020
3 OrthoPediatrics Corp II Jul-10-2020
4 Paragon 28, Inc. II Sep-22-2022
5 Riverpoint Medical, LLC II Dec-08-2023
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 Sep-28-2023
10 Stryker Corporation II Mar-02-2020
11 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
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