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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 2
AJU PHARM CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANIKA THERAPEUTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 14
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 4
BAAT MEDICAL PRODUCTS B.V.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 4
CONEXTIONS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DUNAMIS LLC
  SUBSTANTIALLY EQUIVALENT 1
FIELD ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
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 6
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 5
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-DESIGN (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 2
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
OTS MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 8
PARCUS MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL LLC.
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 6
RESPONSIVE ARTHROSCOPY LLC
  SUBSTANTIALLY EQUIVALENT 5
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 10
RIVERPOINT MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
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
SKELETAL DYNAMICS 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 3
TIGON MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
VALERIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VALERIS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
YUNYI (BEIJING) MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1453 1453
2021 1890 1890
2022 1586 1586
2023 2506 2506
2024 3766 3770

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4032 4032
Device-Device Incompatibility 1260 1260
Device Dislodged or Dislocated 783 783
Adverse Event Without Identified Device or Use Problem 780 784
Fracture 684 684
Detachment of Device or Device Component 412 412
Physical Resistance/Sticking 276 276
Migration 272 272
Material Split, Cut or Torn 257 257
Migration or Expulsion of Device 211 211
Difficult to Advance 198 198
Material Separation 190 190
Material Deformation 184 184
Failure to Advance 172 172
Material Twisted/Bent 156 156
Premature Activation 150 150
Material Fragmentation 148 148
Mechanical Jam 131 131
Insufficient Information 128 128
Positioning Failure 127 127
Defective Device 123 123
Crack 115 115
Use of Device Problem 92 92
Unintended Movement 90 90
Packaging Problem 85 85
Patient Device Interaction Problem 68 68
Expiration Date Error 66 66
Difficult to Insert 61 61
Failure to Fire 60 60
Difficult or Delayed Activation 57 57
Material Frayed 56 56
Delivered as Unsterile Product 49 49
Fitting Problem 46 46
Corroded 44 44
Separation Failure 43 43
Appropriate Term/Code Not Available 40 40
Firing Problem 37 37
Entrapment of Device 32 32
Device Damaged Prior to Use 31 31
Mechanical Problem 26 26
Loosening of Implant Not Related to Bone-Ingrowth 25 25
Expulsion 25 25
Component Missing 25 25
Difficult to Remove 22 22
Device Contaminated During Manufacture or Shipping 22 22
Unsealed Device Packaging 20 20
Premature Separation 19 19
Loose or Intermittent Connection 19 19
Activation, Positioning or Separation Problem 19 19
Unstable 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7446 7446
Insufficient Information 1043 1043
Foreign Body In Patient 668 668
No Known Impact Or Consequence To Patient 298 298
No Information 297 297
No Consequences Or Impact To Patient 276 276
Unspecified Tissue Injury 236 236
Failure of Implant 204 204
Perforation 203 203
Pain 139 139
Device Embedded In Tissue or Plaque 136 136
Rupture 131 131
Unspecified Infection 109 109
Injury 97 97
Not Applicable 87 87
Loss of Range of Motion 58 58
Damage to Ligament(s) 50 50
Swelling/ Edema 42 42
Joint Dislocation 35 35
Hypersensitivity/Allergic reaction 34 34
Muscle/Tendon Damage 33 33
No Code Available 28 28
Post Operative Wound Infection 28 28
Osteolysis 27 27
Scar Tissue 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Joint Laxity 23 23
Bone Fracture(s) 18 18
Adhesion(s) 14 14
Inflammation 14 14
Fibrosis 14 14
No Patient Involvement 14 14
Hematoma 13 13
Synovitis 11 11
Foreign Body Reaction 11 11
Wound Dehiscence 10 10
Muscular Rigidity 10 10
Bacterial Infection 10 10
Ossification 10 10
Skin Inflammation/ Irritation 9 9
Discomfort 9 13
Nerve Damage 9 9
Impaired Healing 9 9
Arthritis 9 9
Fever 9 9
Thrombosis/Thrombus 9 9
Tissue Damage 8 8
Cyst(s) 7 7
Laceration(s) 7 7
Fluid Discharge 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 OrthoPediatrics Corp II Jul-10-2020
3 Paragon 28, Inc. II Sep-22-2022
4 Riverpoint Medical, LLC II Dec-08-2023
5 Smith & Nephew Inc. II Nov-29-2024
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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