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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 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
  1.  K202355  Stryker Omega PEEK Knotless Anchor System
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 3470 3470

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4167 4167
Device-Device Incompatibility 1276 1276
Adverse Event Without Identified Device or Use Problem 801 801
Device Dislodged or Dislocated 799 799
Fracture 771 771
Detachment of Device or Device Component 451 451
Material Separation 356 356
Material Split, Cut or Torn 307 307
Migration 289 289
Migration or Expulsion of Device 274 274
Physical Resistance/Sticking 270 270
Insufficient Information 219 219
Positioning Failure 208 208
Difficult to Advance 195 195
Material Twisted/Bent 191 191
Material Deformation 187 187
Failure to Advance 187 187
Material Fragmentation 162 162
Mechanical Jam 156 156
Premature Activation 150 150
Crack 124 124
Defective Device 122 122
Unintended Movement 91 91
Use of Device Problem 90 90
Appropriate Term/Code Not Available 88 88
Packaging Problem 85 85
Expiration Date Error 73 73
Patient Device Interaction Problem 71 71
Material Frayed 66 66
Difficult to Insert 63 63
Failure to Fire 61 61
Difficult or Delayed Activation 55 55
Delivered as Unsterile Product 52 52
Corroded 51 51
Separation Failure 49 49
Fitting Problem 46 46
Activation, Positioning or Separation Problem 43 43
Entrapment of Device 40 40
Firing Problem 38 38
Loose or Intermittent Connection 33 33
Mechanical Problem 32 32
Device Damaged Prior to Use 31 31
Loosening of Implant Not Related to Bone-Ingrowth 31 31
Device Slipped 29 29
Component Missing 28 28
Difficult to Remove 28 28
Expulsion 26 26
Device Contaminated During Manufacture or Shipping 24 24
Unsealed Device Packaging 22 22
Unstable 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7217 7217
Insufficient Information 1012 1012
No Known Impact Or Consequence To Patient 770 770
Foreign Body In Patient 727 727
No Consequences Or Impact To Patient 587 587
No Information 348 348
Not Applicable 240 240
Unspecified Tissue Injury 233 233
Failure of Implant 214 214
Perforation 181 181
Pain 172 172
Device Embedded In Tissue or Plaque 156 156
Injury 156 156
Rupture 132 132
Unspecified Infection 123 123
No Code Available 100 100
Loss of Range of Motion 62 62
Damage to Ligament(s) 49 49
No Patient Involvement 47 47
Swelling/ Edema 42 42
Joint Dislocation 37 37
Hypersensitivity/Allergic reaction 35 35
Muscle/Tendon Damage 33 33
Post Operative Wound Infection 28 28
Osteolysis 27 27
Scar Tissue 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Tissue Damage 23 23
Joint Laxity 23 23
Bone Fracture(s) 21 21
Inflammation 21 21
Adhesion(s) 16 16
Swelling 14 14
Fibrosis 14 14
Hematoma 13 13
Synovitis 11 11
Cyst(s) 11 11
Foreign Body Reaction 11 11
Ossification 10 10
Muscular Rigidity 10 10
Discomfort 10 10
Bacterial Infection 10 10
Wound Dehiscence 10 10
Skin Inflammation/ Irritation 9 9
Fever 9 9
Arthritis 9 9
Thrombosis/Thrombus 9 9
Erythema 9 9
Nerve Damage 9 9
Impaired Healing 9 9

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 Nov-29-2024
7 Smith & Nephew, Inc. II Jul-31-2020
8 Smith & Nephew, Inc. II Apr-22-2020
9 Smith & Nephew, Inc. II Feb-19-2020
10 Stryker Corporation II Sep-28-2023
11 Stryker Corporation II Mar-02-2020
12 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
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