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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 1
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 13
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
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 1
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 7
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 9
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
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 12
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 2504 2504
2024 1120 1120

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4734 4734
Device-Device Incompatibility 1129 1129
Adverse Event Without Identified Device or Use Problem 990 990
Fracture 871 871
Device Dislodged or Dislocated 651 651
Migration or Expulsion of Device 466 466
Detachment of Device or Device Component 429 429
Material Separation 373 373
Insufficient Information 332 332
Migration 274 274
Positioning Failure 263 263
Material Fragmentation 214 214
Detachment Of Device Component 198 198
Physical Resistance/Sticking 188 188
Activation, Positioning or Separation Problem 180 180
Material Twisted/Bent 173 173
Difficult to Advance 170 170
Material Split, Cut or Torn 166 166
Material Deformation 164 164
Device Operates Differently Than Expected 163 163
Mechanical Jam 162 162
Crack 128 128
Failure to Advance 118 118
Appropriate Term/Code Not Available 110 110
Premature Activation 102 102
Device Slipped 101 101
Difficult to Insert 98 98
Unintended Movement 92 92
Loose or Intermittent Connection 88 88
Bent 80 80
Packaging Problem 76 76
Defective Device 75 75
Expiration Date Error 71 71
Difficult to Remove 71 71
Unknown (for use when the device problem is not known) 66 66
Material Frayed 65 65
Positioning Problem 60 60
Use of Device Problem 58 58
Patient Device Interaction Problem 57 57
Entrapment of Device 54 54
Separation Failure 54 54
Corroded 52 52
Delivered as Unsterile Product 50 50
Component Missing 46 46
Failure to Fire 46 46
Difficult or Delayed Activation 41 41
Expulsion 40 40
Mechanical Problem 39 39
Firing Problem 39 39
Sticking 38 38
Component Falling 34 34
Unsealed Device Packaging 31 31
Device Contaminated During Manufacture or Shipping 29 29
Device Damaged Prior to Use 28 28
Loosening of Implant Not Related to Bone-Ingrowth 27 27
Improper or Incorrect Procedure or Method 25 25
Malposition of Device 25 25
Unstable 22 22
Fitting Problem 21 21
Patient-Device Incompatibility 19 19
Device Contamination with Chemical or Other Material 19 19
Material Integrity Problem 18 18
Noise, Audible 18 18
Activation Problem 16 16
Device Markings/Labelling Problem 16 16
Manufacturing, Packaging or Shipping Problem 15 15
Difficult or Delayed Positioning 15 15
Disassembly 15 15
Inaccurate Information 14 14
Component Misassembled 14 14
Mechanics Altered 14 14
Output Problem 13 13
Premature Separation 13 13
Unraveled Material 13 13
Material Rupture 13 13
Connection Problem 13 13
Cut In Material 12 12
Separation Problem 12 12
Therapeutic or Diagnostic Output Failure 11 11
Device Or Device Fragments Location Unknown 11 11
Misfire 11 11
Tear, Rip or Hole in Device Packaging 11 11
Material Protrusion/Extrusion 11 11
Deformation Due to Compressive Stress 10 10
Material Disintegration 10 10
Disconnection 9 9
Device Expiration Issue 9 9
Metal Shedding Debris 9 9
Retraction Problem 9 9
Difficult to Fold, Unfold or Collapse 9 9
Nonstandard Device 8 8
Difficult To Position 8 8
Contamination 8 8
Loss of or Failure to Bond 8 8
Contamination /Decontamination Problem 8 8
Torn Material 8 8
Failure to Eject 8 8
Device Fell 7 7
Activation Failure 7 7
Failure to Disconnect 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5496 5496
No Known Impact Or Consequence To Patient 2266 2266
No Consequences Or Impact To Patient 1138 1138
No Information 800 800
Foreign Body In Patient 765 765
Insufficient Information 680 680
Device Embedded In Tissue or Plaque 357 357
No Code Available 340 340
Not Applicable 287 287
Pain 267 267
Failure of Implant 193 193
Injury 182 182
Unspecified Tissue Injury 179 179
Unspecified Infection 165 165
Rupture 133 133
Tissue Damage 128 128
Perforation 119 119
No Patient Involvement 76 76
Loss of Range of Motion 65 65
Damage to Ligament(s) 47 47
Bone Fracture(s) 45 45
Hypersensitivity/Allergic reaction 41 41
Swelling 37 37
Swelling/ Edema 36 36
Joint Dislocation 34 34
Post Operative Wound Infection 31 31
Osteolysis 30 30
Inflammation 30 30
Scar Tissue 28 28
Unknown (for use when the patient's condition is not known) 27 27
Muscle/Tendon Damage 26 26
Surgical procedure, repeated 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Cyst(s) 22 22
Joint Laxity 16 16
Erythema 15 15
Adhesion(s) 15 15
Hematoma 15 15
Arthritis 13 13
Nerve Damage 13 13
Fibrosis 13 13
Discomfort 13 13
Reaction 12 12
Muscular Rigidity 12 12
Ossification 12 12
Foreign Body Reaction 11 11
Fever 10 10
Synovitis 10 10
Complaint, Ill-Defined 10 10
Impaired Healing 9 9
Skin Inflammation/ Irritation 9 9
Irritation 9 9
Bacterial Infection 9 9
Erosion 8 8
Wound Dehiscence 8 8
Laceration(s) 8 8
Necrosis 8 8
Thrombosis/Thrombus 8 8
Non-union Bone Fracture 7 7
Patient Problem/Medical Problem 7 7
Purulent Discharge 7 7
Fistula 6 6
Skin Discoloration 6 6
Fluid Discharge 6 6
Subcutaneous Nodule 5 5
Excessive Tear Production 5 5
Neuropathy 5 5
Staphylococcus Aureus 5 5
Fall 5 5
Failure to Anastomose 4 4
Incontinence 4 4
Skin Irritation 4 4
Limited Mobility Of The Implanted Joint 4 4
Numbness 4 4
Surgical procedure, delayed 4 4
Subluxation 4 4
Nodule 3 3
Malunion of Bone 3 3
Skin Infection 3 3
Implant Pain 3 3
Alteration in Body Temperature 3 3
Tissue Breakdown 3 3
Joint Swelling 3 3
Deformity/ Disfigurement 3 3
Disability 3 3
Pneumothorax 3 3
Rash 3 3
Granuloma 3 3
Abscess 3 3
Vessel Or Plaque, Device Embedded In 2 2
Bruise/Contusion 2 2
Death 2 2
Debris, Bone Shedding 2 2
Dyspnea 2 2
Edema 2 2
Hemorrhage/Bleeding 2 2
Itching Sensation 2 2
Local Reaction 2 2
Muscle Weakness 2 2
Other (for use when an appropriate patient code cannot be identified) 2 2

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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