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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
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 7
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 1
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 2504 2504
2024 1120 1120

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3439 3439
Device-Device Incompatibility 1107 1107
Adverse Event Without Identified Device or Use Problem 691 691
Fracture 646 646
Device Dislodged or Dislocated 532 532
Detachment of Device or Device Component 359 359
Material Separation 352 352
Migration or Expulsion of Device 272 272
Migration 260 260
Insufficient Information 211 211
Physical Resistance/Sticking 181 181
Difficult to Advance 157 157
Material Deformation 149 149
Material Split, Cut or Torn 149 149
Material Twisted/Bent 146 146
Positioning Failure 144 144
Mechanical Jam 138 138
Material Fragmentation 132 132
Crack 108 108
Failure to Advance 91 91
Unintended Movement 84 84
Premature Activation 83 83
Appropriate Term/Code Not Available 81 81
Defective Device 74 74
Expiration Date Error 70 70
Packaging Problem 68 68
Patient Device Interaction Problem 57 57
Use of Device Problem 54 54
Difficult to Insert 54 54
Corroded 51 51
Delivered as Unsterile Product 48 48
Activation, Positioning or Separation Problem 43 43
Separation Failure 41 41
Difficult or Delayed Activation 41 41
Failure to Fire 41 41
Entrapment of Device 40 40
Material Frayed 39 39
Firing Problem 38 38
Loose or Intermittent Connection 33 33
Device Slipped 29 29
Difficult to Remove 28 28
Mechanical Problem 26 26
Component Missing 25 25
Device Contaminated During Manufacture or Shipping 23 23
Device Damaged Prior to Use 21 21
Unsealed Device Packaging 20 20
Expulsion 20 20
Loosening of Implant Not Related to Bone-Ingrowth 19 19
Unstable 18 18
Positioning Problem 17 17
Inaccurate Information 14 14
Activation Problem 14 14
Fitting Problem 14 14
Improper or Incorrect Procedure or Method 13 13
Output Problem 13 13
Manufacturing, Packaging or Shipping Problem 13 13
Premature Separation 12 12
Noise, Audible 12 12
Patient-Device Incompatibility 12 12
Component Misassembled 11 11
Therapeutic or Diagnostic Output Failure 11 11
Material Integrity Problem 11 11
Deformation Due to Compressive Stress 10 10
Separation Problem 10 10
Tear, Rip or Hole in Device Packaging 10 10
Material Rupture 9 9
Difficult to Fold, Unfold or Collapse 9 9
Connection Problem 9 9
Failure to Eject 8 8
Nonstandard Device 8 8
Contamination 7 7
Device Markings/Labelling Problem 7 7
Activation Failure 7 7
No Apparent Adverse Event 6 6
Contamination /Decontamination Problem 6 6
Device Fell 6 6
Degraded 6 6
Difficult or Delayed Positioning 6 6
Malposition of Device 6 6
Defective Component 5 5
Disconnection 5 5
Product Quality Problem 5 5
Material Disintegration 4 4
Failure to Discharge 4 4
Inadequacy of Device Shape and/or Size 4 4
Misfire 4 4
Ejection Problem 4 4
Device Handling Problem 3 3
Failure to Disconnect 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
Incorrect Measurement 2 2
Unintended Ejection 2 2
Loss of or Failure to Bond 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5496 5496
No Known Impact Or Consequence To Patient 770 770
Insufficient Information 680 680
Foreign Body In Patient 595 595
No Consequences Or Impact To Patient 587 587
No Information 348 348
Not Applicable 240 240
Unspecified Tissue Injury 179 179
Failure of Implant 174 174
Pain 159 159
Injury 156 156
Device Embedded In Tissue or Plaque 136 136
Rupture 132 132
Unspecified Infection 111 111
Perforation 109 109
No Code Available 100 100
Loss of Range of Motion 59 59
No Patient Involvement 47 47
Damage to Ligament(s) 46 46
Swelling/ Edema 36 36
Joint Dislocation 31 31
Hypersensitivity/Allergic reaction 30 30
Muscle/Tendon Damage 26 26
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
Hematoma 13 13
Fibrosis 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
Subcutaneous Nodule 5 5
Purulent Discharge 5 5
Discomfort 5 5
Skin Discoloration 5 5
Neuropathy 4 4
Numbness 4 4
Bacterial Infection 4 4
Non-union Bone Fracture 4 4
Fluid Discharge 4 4
Subluxation 4 4
Nodule 3 3
Implant Pain 3 3
Alteration in Body Temperature 3 3
Malunion of Bone 3 3
Skin Infection 3 3
Abscess 3 3
Fistula 3 3
Necrosis 3 3
Reaction 3 3
Excessive Tear Production 3 3
Ulcer 2 2
Pneumothorax 2 2
Local Reaction 2 2
Fungal Infection 2 2
Irritability 2 2
Incontinence 2 2
Granuloma 2 2
Bruise/Contusion 2 2
Skin Disorders 2 2
Osteomyelitis 2 2
Unspecified Musculoskeletal problem 1 1
Blister 1 1
Localized Skin Lesion 1 1
Reaction to Medicinal Component of Device 1 1
Solid Tumour 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
Cerebrospinal Fluid Leakage 1 1
Chest Pain 1 1
Death 1 1
Edema 1 1
Vessel Or Plaque, Device Embedded In 1 1
Erosion 1 1
Failure to Anastomose 1 1
Hemorrhage/Bleeding 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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