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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 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
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 9
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 9
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-DESIGN (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 2
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 8
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
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 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 2647 2647

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3875 3875
Device-Device Incompatibility 1197 1197
Device Dislodged or Dislocated 739 739
Adverse Event Without Identified Device or Use Problem 718 718
Fracture 711 711
Detachment of Device or Device Component 422 422
Material Separation 356 356
Migration 281 281
Migration or Expulsion of Device 274 274
Material Split, Cut or Torn 270 270
Physical Resistance/Sticking 246 246
Insufficient Information 217 217
Positioning Failure 194 194
Difficult to Advance 183 183
Material Twisted/Bent 179 179
Material Deformation 170 170
Failure to Advance 169 169
Material Fragmentation 145 145
Mechanical Jam 145 145
Premature Activation 127 127
Defective Device 117 117
Crack 115 115
Unintended Movement 90 90
Use of Device Problem 84 84
Appropriate Term/Code Not Available 82 82
Packaging Problem 77 77
Expiration Date Error 71 71
Patient Device Interaction Problem 66 66
Material Frayed 62 62
Difficult to Insert 58 58
Corroded 51 51
Delivered as Unsterile Product 51 51
Separation Failure 47 47
Failure to Fire 46 46
Difficult or Delayed Activation 44 44
Fitting Problem 44 44
Activation, Positioning or Separation Problem 43 43
Entrapment of Device 40 40
Firing Problem 38 38
Loose or Intermittent Connection 33 33
Device Damaged Prior to Use 31 31
Mechanical Problem 31 31
Device Slipped 29 29
Difficult to Remove 28 28
Component Missing 27 27
Device Contaminated During Manufacture or Shipping 24 24
Expulsion 23 23
Loosening of Implant Not Related to Bone-Ingrowth 23 23
Unsealed Device Packaging 21 21
Unstable 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6668 6668
Insufficient Information 918 918
No Known Impact Or Consequence To Patient 770 770
Foreign Body In Patient 668 668
No Consequences Or Impact To Patient 587 587
No Information 348 348
Not Applicable 240 240
Failure of Implant 200 200
Unspecified Tissue Injury 190 190
Pain 165 165
Injury 156 156
Device Embedded In Tissue or Plaque 142 142
Perforation 140 140
Rupture 132 132
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 37 37
Joint Dislocation 33 33
Hypersensitivity/Allergic reaction 32 32
Muscle/Tendon Damage 28 28
Post Operative Wound Infection 25 25
Scar Tissue 25 25
Osteolysis 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Tissue Damage 23 23
Bone Fracture(s) 21 21
Inflammation 19 19
Joint Laxity 17 17
Adhesion(s) 16 16
Fibrosis 14 14
Swelling 14 14
Hematoma 13 13
Cyst(s) 11 11
Foreign Body Reaction 11 11
Muscular Rigidity 10 10
Ossification 10 10
Skin Inflammation/ Irritation 9 9
Arthritis 9 9
Synovitis 8 8
Erythema 8 8
Thrombosis/Thrombus 8 8
Wound Dehiscence 8 8
Impaired Healing 8 8
Nerve Damage 7 7
Fever 7 7
Irritation 6 6
Laceration(s) 6 6

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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