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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fastener, fixation, biodegradable, soft tissue
Product CodeMAI
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ACUITIVE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ACUITIVE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
AJU PHARM CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 17
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 12
B-ONE ORTHO, CORP
  SUBSTANTIALLY EQUIVALENT 1
BIORETEC LTD
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CONMED LINVATEC
  SUBSTANTIALLY EQUIVALENT 2
DEPUY MITEK
  SUBSTANTIALLY EQUIVALENT 2
DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY
  SUBSTANTIALLY EQUIVALENT 1
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
  SUBSTANTIALLY EQUIVALENT 15
DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY
  SUBSTANTIALLY EQUIVALENT 2
EMBODY, INC.
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC CORP.
  SUBSTANTIALLY EQUIVALENT 2
LINVATEC CORPORATION D/B/A CONMED LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 8
NANOFIBER SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 4
NANOVA BIOMATERIALS INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOVA BIOMATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSSIO LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
PARCUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
S.B.M SAS SCIENCE FOR BIO MATERIALS
  SUBSTANTIALLY EQUIVALENT 1
S.B.M. SAS SCIENCES FOR BIO MATERIALS
  SUBSTANTIALLY EQUIVALENT 1
SBM SCIENCES FOR BIO MATERIALS
  SUBSTANTIALLY EQUIVALENT 1
SCIENCE & BIO MATERIALS (S.B.M.) SAS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW ENDOSCOPY, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW INC., ENDOSCOPY DIVISION
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 6
SMITH AND NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH AND NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPORTWELDING GMBH
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL FUSION TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 1
TEKNIMED
  SUBSTANTIALLY EQUIVALENT 1
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIPTEK, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 149 149
2015 182 182
2016 301 301
2017 478 478
2018 1590 1590
2019 1247 1247
2020 957 957
2021 1267 1267
2022 1432 1432
2023 1720 1720
2024 1585 1585

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5875 5875
Adverse Event Without Identified Device or Use Problem 973 973
Device-Device Incompatibility 484 484
Crack 315 315
Detachment of Device or Device Component 298 298
Migration 281 281
Material Deformation 258 258
Device Dislodged or Dislocated 236 236
Fracture 220 220
Migration or Expulsion of Device 186 186
Insufficient Information 152 152
Positioning Failure 149 149
Material Twisted/Bent 142 142
Difficult to Advance 131 131
Premature Activation 129 129
Material Separation 128 128
Activation, Positioning or Separation Problem 116 116
Material Split, Cut or Torn 99 99
Device Damaged Prior to Use 93 93
Material Fragmentation 91 91
Material Frayed 87 87
Failure to Advance 82 82
Mechanical Jam 81 81
Appropriate Term/Code Not Available 76 76
Detachment Of Device Component 72 72
Loose or Intermittent Connection 71 71
Entrapment of Device 62 62
Patient Device Interaction Problem 60 60
Patient-Device Incompatibility 57 57
Difficult to Insert 54 54
Defective Device 52 52
Difficult to Remove 49 49
Unintended Movement 45 45
Physical Resistance/Sticking 41 41
Use of Device Problem 40 40
Deformation Due to Compressive Stress 39 39
Unknown (for use when the device problem is not known) 39 39
Device Operates Differently Than Expected 27 27
Positioning Problem 26 26
Loosening of Implant Not Related to Bone-Ingrowth 26 26
Mechanical Problem 26 26
Device Slipped 26 26
Bent 23 23
Activation Problem 22 22
Separation Failure 20 20
Device Contaminated During Manufacture or Shipping 20 20
Tip breakage 18 18
Delivered as Unsterile Product 17 17
Packaging Problem 17 17
Firing Problem 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4609 4609
No Consequences Or Impact To Patient 2237 2238
No Known Impact Or Consequence To Patient 742 742
Insufficient Information 468 468
Foreign Body In Patient 413 413
Unspecified Tissue Injury 376 376
Not Applicable 371 371
No Code Available 364 364
Unspecified Infection 306 306
Tissue Damage 251 251
Pain 241 242
Injury 221 221
Device Embedded In Tissue or Plaque 201 202
No Information 187 187
Failure of Implant 178 178
Swelling 68 68
Inflammation 64 64
Hypersensitivity/Allergic reaction 55 55
Reaction 48 48
Loss of Range of Motion 48 48
Rupture 44 44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Foreign Body Reaction 41 41
Perforation 40 40
Nerve Damage 35 35
Swelling/ Edema 30 30
Unknown (for use when the patient's condition is not known) 27 27
Rash 27 27
Cyst(s) 22 22
Impaired Healing 20 20
Joint Laxity 20 20
Discomfort 20 20
Osteolysis 17 17
Post Operative Wound Infection 17 17
No Patient Involvement 16 16
Damage to Ligament(s) 15 15
Erythema 15 15
Bacterial Infection 15 15
Fluid Discharge 15 15
Abscess 14 14
Fever 13 13
Adhesion(s) 12 12
Synovitis 12 12
Surgical procedure, repeated 12 12
Joint Dislocation 11 11
Hemorrhage/Bleeding 11 11
Bone Fracture(s) 10 10
Scar Tissue 10 10
Itching Sensation 10 10
Hematoma 9 9

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Jul-21-2021
2 Arthrex, Inc. II May-05-2017
3 DePuy Mitek, Inc., a Johnson & Johnson Co. II Jun-02-2023
4 DePuy Mitek, Inc., a Johnson & Johnson Co. II Dec-10-2019
5 DePuy Mitek, Inc., a Johnson & Johnson Co. II Mar-06-2012
6 DePuy Mitek, Inc., a Johnson & Johnson Co. II Nov-30-2011
7 Linvatec Corp. dba ConMed Linvatec II Jul-01-2013
8 Smith & Nephew, Inc. II Apr-29-2021
9 Smith & Nephew, Inc. II Oct-21-2020
10 Smith & Nephew, Inc. II Apr-26-2018
11 Smith & Nephew, Inc. II Sep-07-2016
12 Smith & Nephew, Inc. Endoscopy Division II Sep-17-2013
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