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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 3
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AJU PHARM CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANIKA THERAPEUTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 20
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 4
BAAT MEDICAL PRODUCTS B.V.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 6
CAYENNE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CAYENNE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
CONEXTIONS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
COUSIN BIOTECH S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DUNAMIS LLC
  SUBSTANTIALLY EQUIVALENT 2
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 3
ICONN ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
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 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 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
OXFORD PERFORMANCE MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC
  SUBSTANTIALLY EQUIVALENT 2
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 6
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 4
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
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 3
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 4
SUBCHONDRAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU ENDOPHIX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD
  SUBSTANTIALLY EQUIVALENT 4
THE ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TIGON MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
U & I CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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
2018 1072 1072
2019 1303 1303
2020 1453 1453
2021 1889 1889
2022 1586 1586
2023 1909 1909

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3285 3285
Device-Device Incompatibility 988 988
Adverse Event Without Identified Device or Use Problem 671 671
Fracture 601 601
Migration or Expulsion of Device 384 384
Material Separation 360 360
Device Dislodged or Dislocated 343 343
Detachment of Device or Device Component 311 311
Migration 233 233
Insufficient Information 230 230
Positioning Failure 187 187
Mechanical Jam 141 141
Difficult to Advance 133 133
Physical Resistance/Sticking 129 129
Material Twisted/Bent 125 125
Material Split, Cut or Torn 123 123
Material Fragmentation 122 122
Material Deformation 121 121
Crack 106 106
Appropriate Term/Code Not Available 84 84
Activation, Positioning or Separation Problem 79 79
Failure to Advance 74 74
Expiration Date Error 64 64
Difficult to Insert 60 60
Packaging Problem 56 56
Corroded 51 51
Entrapment of Device 49 49
Unintended Movement 49 49
Loose or Intermittent Connection 41 41
Delivered as Unsterile Product 41 41
Material Frayed 39 39
Separation Failure 39 39
Expulsion 36 36
Firing Problem 36 36
Premature Activation 36 36
Difficult to Remove 35 35
Detachment Of Device Component 35 35
Patient Device Interaction Problem 34 34
Failure to Fire 33 33
Device Slipped 33 33
Use of Device Problem 32 32
Difficult or Delayed Activation 30 30
Positioning Problem 28 28
Component Missing 26 26
Mechanical Problem 25 25
Defective Device 24 24
Device Contaminated During Manufacture or Shipping 24 24
Loosening of Implant Not Related to Bone-Ingrowth 23 23
Device Operates Differently Than Expected 21 21
Device Damaged Prior to Use 21 21
Unsealed Device Packaging 20 20
Bent 18 18
Device Markings/Labelling Problem 16 16
Activation Problem 15 15
Inaccurate Information 14 14
Manufacturing, Packaging or Shipping Problem 14 14
Device Contamination with Chemical or Other Material 14 14
Patient-Device Incompatibility 14 14
Unstable 14 14
Output Problem 13 13
Separation Problem 12 12
Component Misassembled 12 12
Material Integrity Problem 12 12
Unraveled Material 12 12
Improper or Incorrect Procedure or Method 11 11
Therapeutic or Diagnostic Output Failure 11 11
Premature Separation 11 11
Connection Problem 9 9
Tear, Rip or Hole in Device Packaging 9 9
Difficult to Fold, Unfold or Collapse 9 9
Nonstandard Device 8 8
Malposition of Device 8 8
Contamination /Decontamination Problem 8 8
Noise, Audible 8 8
Device Fell 7 7
Deformation Due to Compressive Stress 7 7
Material Rupture 7 7
Material Disintegration 6 6
Difficult or Delayed Positioning 6 6
Misfire 6 6
Failure to Eject 6 6
No Apparent Adverse Event 6 6
Degraded 5 5
Loss of or Failure to Bond 5 5
Disconnection 5 5
Defective Component 5 5
Material Puncture/Hole 5 5
Failure to Discharge 4 4
Contamination 4 4
Ejection Problem 4 4
Device Handling Problem 4 4
Activation Failure 4 4
Mechanics Altered 3 3
Failure to Disconnect 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Material Protrusion/Extrusion 3 3
Component Falling 3 3
Device Expiration Issue 3 3
Incorrect Measurement 3 3
Product Quality Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4295 4295
No Known Impact Or Consequence To Patient 1269 1269
No Consequences Or Impact To Patient 898 898
Foreign Body In Patient 521 521
No Information 391 391
Insufficient Information 384 384
Not Applicable 284 284
Unspecified Tissue Injury 172 172
Pain 169 169
Device Embedded In Tissue or Plaque 167 167
Injury 163 163
Failure of Implant 158 158
No Code Available 146 146
Rupture 130 130
Unspecified Infection 96 96
Tissue Damage 58 58
Loss of Range of Motion 55 55
Perforation 51 51
No Patient Involvement 51 51
Damage to Ligament(s) 46 46
Swelling/ Edema 35 35
Bone Fracture(s) 29 29
Hypersensitivity/Allergic reaction 28 28
Joint Dislocation 28 28
Osteolysis 25 25
Scar Tissue 25 25
Post Operative Wound Infection 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Muscle/Tendon Damage 18 18
Joint Laxity 16 16
Inflammation 16 16
Adhesion(s) 15 15
Swelling 14 14
Hematoma 13 13
Fibrosis 13 13
Cyst(s) 12 12
Ossification 10 10
Muscular Rigidity 10 10
Arthritis 8 8
Thrombosis/Thrombus 8 8
Skin Inflammation/ Irritation 7 7
Erythema 7 7
Fever 7 7
Foreign Body Reaction 7 7
Synovitis 7 7
Nerve Damage 7 7
Impaired Healing 7 7
Irritation 6 6
Patient Problem/Medical Problem 6 6
Subcutaneous Nodule 5 5
Laceration(s) 5 5
Purulent Discharge 5 5
Wound Dehiscence 5 5
Discomfort 5 5
Skin Discoloration 5 5
Neuropathy 4 4
Non-union Bone Fracture 4 4
Excessive Tear Production 4 4
Bacterial Infection 4 4
Numbness 4 4
Subluxation 4 4
Limited Mobility Of The Implanted Joint 3 3
Nodule 3 3
Implant Pain 3 3
Malunion of Bone 3 3
Skin Infection 3 3
Abscess 3 3
Fistula 3 3
Necrosis 3 3
Reaction 3 3
Needle Stick/Puncture 2 2
Pneumothorax 2 2
Local Reaction 2 2
Granuloma 2 2
Incontinence 2 2
Bruise/Contusion 2 2
Vessel Or Plaque, Device Embedded In 2 2
Skin Disorders 2 2
Alteration in Body Temperature 2 2
Fungal Infection 2 2
Irritability 2 2
Fluid Discharge 2 2
Hyperesthesia 1 1
Paresthesia 1 1
Tissue Breakdown 1 1
Reaction to Medicinal Component of Device 1 1
Solid Tumour 1 1
Ankylosis 1 1
Osteomyelitis 1 1
Unspecified Musculoskeletal problem 1 1
Blister 1 1
Localized Skin Lesion 1 1
Erosion 1 1
Cerebrospinal Fluid Leakage 1 1
Chest Pain 1 1
Death 1 1
Edema 1 1
Hemorrhage/Bleeding 1 1
Failure to Anastomose 1 1
Itching Sensation 1 1

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 Smith & Nephew, Inc. II Jul-31-2020
6 Smith & Nephew, Inc. II Apr-22-2020
7 Smith & Nephew, Inc. II Feb-19-2020
8 Stryker Corporation II Sep-28-2023
9 Stryker Corporation II Mar-02-2020
10 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
11 Valeris Medical, LLC II Oct-12-2018
12 Valeris Medical, LLC II Jul-13-2018
13 Zimmer Biomet, Inc. II Sep-26-2018
14 Zimmer Biomet, Inc. II Mar-15-2018
15 Zimmer Biomet, Inc. II Mar-14-2018
16 Zimmer Biomet, Inc. II Mar-01-2018
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