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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
ACUMED, LLC
  SUBSTANTIALLY EQUIVALENT 2
AEVUMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
AJU PHARM CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
AMENDIA INC.
  SUBSTANTIALLY EQUIVALENT 1
ANCHOR INNOVATION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANIKA THERAPEUTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
ANULEX TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 2
ARTHEX, INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHOCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 21
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 14
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 14
ARTHROCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 13
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 4
BAAT MEDICAL PRODUCTS B.V.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 6
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 5
BIOMET SPORTS MEDICINE
  SUBSTANTIALLY EQUIVALENT 6
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAYENNE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CAYENNE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 4
CAYENNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 9
CONEXTIONS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 12
CONMED LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
CORE ESSENCE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
CORE ESSENCE ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COUSIN BIOTECH S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2
D3 DC, LLC /STABILYNX, INC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY
  SUBSTANTIALLY EQUIVALENT 2
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
  SUBSTANTIALLY EQUIVALENT 7
DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY
  SUBSTANTIALLY EQUIVALENT 1
DUNAMIS LLC
  SUBSTANTIALLY EQUIVALENT 4
ELEVEN BLADE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
FIELD ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
FIRST RAY LLC
  SUBSTANTIALLY EQUIVALENT 1
FLOWER ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FOUNDRY NEWCO XI, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOURNITURES HOSPITALIERES INDUSTRIE
  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
ICONN ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 4
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
KATOR LLC
  SUBSTANTIALLY EQUIVALENT 3
KFX MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
LINVATEC CORP.
  SUBSTANTIALLY EQUIVALENT 2
LINVATEC CORPORATION D/B/A CONMED LINVATEC
  SUBSTANTIALLY EQUIVALENT 2
MARUHO MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 4
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 10
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 11
MEDSHAPE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE, INC
  SUBSTANTIALLY EQUIVALENT 3
MORTISE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
MTP SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 2
NCS LAB SRL
  SUBSTANTIALLY EQUIVALENT 2
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-DESIGN (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIATRICS, CORP.
  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 8
PARAGON 28,INC.
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
PARCUS MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL LLC.
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 19
PIVOT MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
PIVOT MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
PONTIS ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
PONTIS ORTHOPAEEICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
RESPONSIVE ARTHROSCOPY LLC
  SUBSTANTIALLY EQUIVALENT 8
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 10
RIVERPOINT MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 4
ROG SPORTS MEDICINE, INC.
  SUBSTANTIALLY EQUIVALENT 5
ROSS CREEK MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ROTATION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
S.B.M. SAS (SCIENCE & BIO MATERIALS)
  SUBSTANTIALLY EQUIVALENT 1
SBM SCIENCES FOR BIO MATERIALS
  SUBSTANTIALLY EQUIVALENT 1
SHOULDER OPTIONS, INC.
  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 ENDOSCOPY, INC.
  SUBSTANTIALLY EQUIVALENT 4
SMITH & NEPHEW INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW INC., ENDOSCOPY DIV.
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 13
SMITH AND NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 8
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 6
SUBCHONDRAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU ENDOPHIX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD
  SUBSTANTIALLY EQUIVALENT 5
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
  SUBSTANTIALLY EQUIVALENT 2
TAG MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
TARSUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
THE ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TIGON MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
TORNIER
  SUBSTANTIALLY EQUIVALENT 1
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 5
U & I CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VALERIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
VALERIS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 5
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 2
YUNYI (BEIJING) MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 503 503
2015 507 507
2016 794 794
2017 674 674
2018 1072 1072
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 5170 5170
Device-Device Incompatibility 1219 1219
Adverse Event Without Identified Device or Use Problem 1017 1017
Fracture 936 936
Device Dislodged or Dislocated 858 858
Detachment of Device or Device Component 492 492
Migration or Expulsion of Device 468 468
Material Separation 377 377
Insufficient Information 338 338
Positioning Failure 313 313
Migration 295 295
Material Split, Cut or Torn 287 287
Physical Resistance/Sticking 253 253
Material Fragmentation 227 227
Material Twisted/Bent 206 206
Detachment Of Device Component 198 198
Failure to Advance 196 196
Difficult to Advance 196 196
Material Deformation 185 185
Activation, Positioning or Separation Problem 180 180
Mechanical Jam 169 169
Device Operates Differently Than Expected 163 163
Premature Activation 146 146
Crack 135 135
Defective Device 118 118
Appropriate Term/Code Not Available 111 111
Difficult to Insert 102 102
Device Slipped 101 101
Unintended Movement 98 98
Loose or Intermittent Connection 88 88
Material Frayed 88 88
Use of Device Problem 88 88
Packaging Problem 85 85
Bent 80 80
Expiration Date Error 72 72
Difficult to Remove 71 71
Patient Device Interaction Problem 66 66
Unknown (for use when the device problem is not known) 66 66
Positioning Problem 61 61
Separation Failure 60 60
Entrapment of Device 54 54
Delivered as Unsterile Product 53 53
Corroded 52 52
Failure to Fire 51 51
Fitting Problem 51 51
Component Missing 48 48
Mechanical Problem 44 44
Difficult or Delayed Activation 44 44
Expulsion 43 43
Firing Problem 39 39

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6668 6668
No Known Impact Or Consequence To Patient 2266 2266
No Consequences Or Impact To Patient 1138 1138
Insufficient Information 918 918
Foreign Body In Patient 838 838
No Information 800 800
Device Embedded In Tissue or Plaque 363 363
No Code Available 340 340
Not Applicable 287 287
Pain 273 273
Failure of Implant 219 219
Unspecified Tissue Injury 190 190
Injury 182 182
Unspecified Infection 165 165
Perforation 150 150
Rupture 133 133
Tissue Damage 128 128
No Patient Involvement 76 76
Loss of Range of Motion 67 67
Damage to Ligament(s) 50 50
Bone Fracture(s) 48 48
Hypersensitivity/Allergic reaction 43 43
Swelling 37 37
Swelling/ Edema 37 37
Joint Dislocation 36 36
Post Operative Wound Infection 31 31
Inflammation 31 31
Osteolysis 30 30
Scar Tissue 28 28
Muscle/Tendon Damage 28 28
Unknown (for use when the patient's condition is not known) 27 27
Surgical procedure, repeated 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Cyst(s) 23 23
Joint Laxity 17 17
Adhesion(s) 16 16
Erythema 15 15
Hematoma 15 15
Discomfort 14 14
Fibrosis 14 14
Arthritis 14 14
Nerve Damage 13 13
Foreign Body Reaction 13 13
Muscular Rigidity 12 12
Ossification 12 12
Reaction 12 12
Synovitis 11 11
Impaired Healing 10 10
Bacterial Infection 10 10
Fever 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Jan-11-2019
2 ArthroCare Corporation II Apr-12-2011
3 Biomet Sports Medicine II Jan-11-2012
4 Biomet, Inc. II Dec-17-2020
5 Biomet, Inc. II May-26-2016
6 Biomet, Inc. II Nov-19-2013
7 Biomet, Inc. II Aug-31-2011
8 Biomet, Inc. II Jul-01-2010
9 Biomet, Inc. II Dec-22-2009
10 ConMed Corporation II Dec-14-2017
11 DePuy Mitek, Inc., a Johnson & Johnson Co. II May-19-2011
12 EXP Pharmaceutical Services Corp II Jul-24-2015
13 Innovatech Medical Resources L.P. II Jan-11-2012
14 Linvatec Corp. dba ConMed Linvatec II Oct-15-2012
15 Linvatec Corp. dba ConMed Linvatec II Jun-29-2011
16 Medshape Solutions, INC. II May-08-2013
17 OrthoPediatrics Corp II Jul-10-2020
18 OrthoPediatrics Corp II Aug-29-2014
19 OrthoPediatrics Corp II Dec-26-2013
20 Paragon 28, Inc. II Sep-22-2022
21 Riverpoint Medical, LLC II Dec-08-2023
22 Smith & Nephew, Inc. II Jul-31-2020
23 Smith & Nephew, Inc. II Apr-22-2020
24 Smith & Nephew, Inc. II Feb-19-2020
25 Smith & Nephew, Inc. Endoscopy Division II Jul-14-2014
26 Smith & Nephew, Inc. Endoscopy Division II Aug-09-2012
27 Stryker Corporation II Sep-28-2023
28 Stryker Corporation II Mar-02-2020
29 Stryker Corporation II May-10-2016
30 Synthes (USA) Products LLC II Jul-07-2016
31 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
32 The Anspach Effort, Inc. II Jun-25-2014
33 Valeris Medical, LLC II Oct-12-2018
34 Valeris Medical, LLC II Jul-13-2018
35 Wright Medical Technology Inc II Oct-18-2011
36 Wright Medical Technology Inc II Mar-04-2011
37 Zimmer Biomet, Inc. II Sep-26-2018
38 Zimmer Biomet, Inc. II Mar-15-2018
39 Zimmer Biomet, Inc. II Mar-14-2018
40 Zimmer Biomet, Inc. II Mar-01-2018
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