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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
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 3
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 803 803

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3354 3354
Device-Device Incompatibility 1083 1083
Adverse Event Without Identified Device or Use Problem 688 688
Fracture 635 635
Device Dislodged or Dislocated 489 489
Material Separation 352 352
Detachment of Device or Device Component 336 336
Migration or Expulsion of Device 271 271
Migration 248 248
Insufficient Information 210 210
Physical Resistance/Sticking 168 168
Difficult to Advance 153 153
Material Deformation 142 142
Material Split, Cut or Torn 142 142
Positioning Failure 141 141
Material Twisted/Bent 138 138
Mechanical Jam 136 136
Material Fragmentation 131 131
Crack 107 107
Failure to Advance 89 89
Appropriate Term/Code Not Available 81 81
Unintended Movement 80 80
Expiration Date Error 70 70
Premature Activation 67 67
Packaging Problem 67 67
Patient Device Interaction Problem 55 55
Difficult to Insert 51 51
Corroded 51 51
Delivered as Unsterile Product 47 47
Use of Device Problem 44 44
Activation, Positioning or Separation Problem 43 43
Defective Device 42 42
Failure to Fire 40 40
Separation Failure 40 40
Entrapment of Device 40 40
Difficult or Delayed Activation 39 39
Firing Problem 38 38
Material Frayed 36 36
Loose or Intermittent Connection 33 33
Device Slipped 29 29
Difficult to Remove 28 28
Mechanical Problem 26 26
Component Missing 24 24
Device Contaminated During Manufacture or Shipping 23 23
Expulsion 20 20
Device Damaged Prior to Use 20 20
Unsealed Device Packaging 20 20
Unstable 18 18
Loosening of Implant Not Related to Bone-Ingrowth 18 18
Positioning Problem 16 16
Activation Problem 14 14
Inaccurate Information 14 14
Output Problem 13 13
Manufacturing, Packaging or Shipping Problem 13 13
Improper or Incorrect Procedure or Method 13 13
Patient-Device Incompatibility 12 12
Noise, Audible 12 12
Premature Separation 12 12
Therapeutic or Diagnostic Output Failure 11 11
Material Integrity Problem 11 11
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
Component Misassembled 9 9
Connection Problem 9 9
Failure to Eject 8 8
Nonstandard Device 8 8
Fitting Problem 8 8
Deformation Due to Compressive Stress 7 7
Device Markings/Labelling Problem 7 7
No Apparent Adverse Event 6 6
Activation Failure 6 6
Device Fell 6 6
Contamination /Decontamination Problem 6 6
Malposition of Device 6 6
Degraded 6 6
Difficult or Delayed Positioning 6 6
Disconnection 5 5
Contamination 5 5
Defective Component 5 5
Inadequacy of Device Shape and/or Size 4 4
Misfire 4 4
Material Disintegration 4 4
Failure to Discharge 4 4
Product Quality Problem 4 4
Ejection Problem 4 4
Device Handling Problem 3 3
Off-Label Use 3 3
Material Puncture/Hole 3 3
Failure to Disconnect 3 3
Unexpected Therapeutic Results 3 3
Unraveled Material 3 3
Biocompatibility 2 2
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5277 5277
No Known Impact Or Consequence To Patient 770 770
Insufficient Information 615 615
No Consequences Or Impact To Patient 587 587
Foreign Body In Patient 572 572
No Information 348 348
Not Applicable 240 240
Unspecified Tissue Injury 177 177
Failure of Implant 173 173
Pain 158 158
Injury 156 156
Device Embedded In Tissue or Plaque 135 135
Rupture 132 132
Unspecified Infection 111 111
No Code Available 100 100
Perforation 97 97
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 29 29
Muscle/Tendon Damage 26 26
Osteolysis 25 25
Scar Tissue 25 25
Post Operative Wound Infection 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Tissue Damage 23 23
Inflammation 18 18
Bone Fracture(s) 18 18
Joint Laxity 16 16
Adhesion(s) 15 15
Swelling 14 14
Hematoma 13 13
Fibrosis 13 13
Ossification 10 10
Cyst(s) 10 10
Skin Inflammation/ Irritation 9 9
Thrombosis/Thrombus 8 8
Erythema 8 8
Wound Dehiscence 8 8
Arthritis 8 8
Muscular Rigidity 8 8
Foreign Body Reaction 7 7
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
Non-union Bone Fracture 4 4
Numbness 4 4
Bacterial Infection 4 4
Fluid Discharge 4 4
Subluxation 4 4
Nodule 3 3
Skin Infection 3 3
Malunion of Bone 3 3
Implant Pain 3 3
Alteration in Body Temperature 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
Granuloma 2 2
Incontinence 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
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
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
Hemorrhage/Bleeding 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 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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