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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 1
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 1585 1585

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4270 4270
Adverse Event Without Identified Device or Use Problem 884 884
Device-Device Incompatibility 460 460
Detachment of Device or Device Component 273 273
Migration 265 265
Crack 259 259
Material Deformation 249 249
Device Dislodged or Dislocated 214 214
Fracture 197 197
Difficult to Advance 128 128
Material Separation 124 124
Premature Activation 108 108
Material Twisted/Bent 96 96
Device Damaged Prior to Use 92 92
Migration or Expulsion of Device 89 89
Material Split, Cut or Torn 89 89
Insufficient Information 68 68
Positioning Failure 65 65
Mechanical Jam 63 63
Failure to Advance 61 61
Patient Device Interaction Problem 59 59
Defective Device 52 52
Entrapment of Device 49 49
Loose or Intermittent Connection 49 49
Unintended Movement 40 40
Appropriate Term/Code Not Available 40 40
Material Frayed 40 40
Physical Resistance/Sticking 39 39
Material Fragmentation 37 37
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
Delivered as Unsterile Product 17 17
Packaging Problem 17 17
Manufacturing, Packaging or Shipping Problem 17 17
Firing Problem 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
Unsealed Device Packaging 8 8
Biocompatibility 8 8
Product Quality Problem 8 8
Device Slipped 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4608 4608
No Consequences Or Impact To Patient 894 894
Insufficient Information 468 468
Unspecified Tissue Injury 376 376
Foreign Body In Patient 327 327
Not Applicable 307 307
Unspecified Infection 260 260
No Known Impact Or Consequence To Patient 170 170
No Code Available 160 160
Failure of Implant 157 157
Tissue Damage 157 157
Injury 156 156
Pain 146 146
No Information 133 133
Device Embedded In Tissue or Plaque 105 105
Inflammation 46 46
Loss of Range of Motion 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Rupture 40 40
Hypersensitivity/Allergic reaction 39 39
Perforation 39 39
Foreign Body Reaction 34 34
Nerve Damage 32 32
Swelling/ Edema 30 30
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
Fluid Discharge 13 13
Abscess 13 13
Reaction 13 13
Hemorrhage/Bleeding 11 11
Joint Dislocation 11 11
Adhesion(s) 11 11
Rash 10 10
Scar Tissue 10 10
Hematoma 9 9
Fever 9 9
Discomfort 9 9
Cyst(s) 8 8
Erythema 8 8
Synovitis 8 8
Bone Fracture(s) 7 7
Muscle/Tendon Damage 7 7
Osteolysis 6 6
Bacterial Infection 6 6
Local Reaction 6 6
Purulent Discharge 5 5

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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