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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
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 12
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
B-ONE ORTHO, CORP
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DEPUY MITEK
  SUBSTANTIALLY EQUIVALENT 2
EMBODY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 2
NANOFIBER SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 4
OSSIO LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
PARCUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
SCIENCE & BIO MATERIALS (S.B.M.) SAS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL FUSION TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 1
TEKNIMED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1247 1247
2020 957 957
2021 1267 1267
2022 1432 1432
2023 1720 1720
2024 1761 1761

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4371 4371
Adverse Event Without Identified Device or Use Problem 900 900
Device-Device Incompatibility 463 463
Detachment of Device or Device Component 279 279
Migration 274 274
Crack 261 261
Material Deformation 255 255
Device Dislodged or Dislocated 225 225
Fracture 198 198
Difficult to Advance 134 134
Material Separation 124 124
Premature Activation 116 116
Material Twisted/Bent 97 97
Device Damaged Prior to Use 93 93
Migration or Expulsion of Device 89 89
Material Split, Cut or Torn 89 89
Positioning Failure 70 70
Insufficient Information 68 68
Failure to Advance 65 65
Mechanical Jam 62 62
Patient Device Interaction Problem 60 60
Defective Device 53 53
Entrapment of Device 49 49
Loose or Intermittent Connection 49 49
Material Frayed 40 40
Appropriate Term/Code Not Available 40 40
Unintended Movement 40 40
Physical Resistance/Sticking 40 40
Material Fragmentation 38 38
Patient-Device Incompatibility 34 34
Difficult to Insert 33 33
Use of Device Problem 32 32
Difficult to Remove 25 25
Device Contaminated During Manufacture or Shipping 20 20
Loosening of Implant Not Related to Bone-Ingrowth 20 20
Firing Problem 17 17
Manufacturing, Packaging or Shipping Problem 17 17
Packaging Problem 17 17
Delivered as Unsterile Product 17 17
Positioning Problem 16 16
Component Missing 13 13
Fitting Problem 12 12
Activation, Positioning or Separation Problem 12 12
Deformation Due to Compressive Stress 11 11
Mechanical Problem 11 11
Output Problem 9 9
Biocompatibility 8 8
Unsealed Device Packaging 8 8
Device Slipped 8 8
Product Quality Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4742 4742
No Consequences Or Impact To Patient 894 894
Insufficient Information 497 497
Unspecified Tissue Injury 385 385
Foreign Body In Patient 335 335
Not Applicable 307 307
Unspecified Infection 261 261
No Known Impact Or Consequence To Patient 170 170
No Code Available 160 160
Failure of Implant 159 159
Tissue Damage 157 157
Injury 156 156
Pain 147 147
No Information 133 133
Device Embedded In Tissue or Plaque 106 106
Inflammation 46 46
Loss of Range of Motion 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Rupture 41 41
Perforation 40 40
Hypersensitivity/Allergic reaction 39 39
Foreign Body Reaction 34 34
Nerve Damage 32 32
Swelling/ Edema 31 31
Joint Laxity 20 20
No Patient Involvement 16 16
Swelling 16 16
Impaired Healing 16 16
Damage to Ligament(s) 14 14
Post Operative Wound Infection 14 14
Abscess 13 13
Reaction 13 13
Fluid Discharge 13 13
Adhesion(s) 11 11
Joint Dislocation 11 11
Hemorrhage/Bleeding 11 11
Scar Tissue 10 10
Rash 10 10
Hematoma 9 9
Discomfort 9 9
Fever 9 9
Cyst(s) 8 8
Synovitis 8 8
Erythema 8 8
Sepsis 8 8
Muscle/Tendon Damage 7 7
Bone Fracture(s) 7 7
Local Reaction 6 6
Bacterial Infection 6 6
Osteolysis 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Jul-21-2021
2 DePuy Mitek, Inc., a Johnson & Johnson Co. II Jun-02-2023
3 DePuy Mitek, Inc., a Johnson & Johnson Co. II Dec-10-2019
4 Smith & Nephew, Inc. II Apr-29-2021
5 Smith & Nephew, Inc. II Oct-21-2020
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