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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
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
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 8
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 3
B-ONE ORTHO, CORP
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DEPUY MITEK
  SUBSTANTIALLY EQUIVALENT 3
EMBODY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
NANOFIBER SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 3
OSSIO LTD.
  SUBSTANTIALLY EQUIVALENT 2
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
PARCUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
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
2020 957 957
2021 1267 1267
2022 1431 1431
2023 1718 1718
2024 2303 2303
2025 453 453

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4689 4689
Adverse Event Without Identified Device or Use Problem 688 688
Device-Device Incompatibility 475 475
Migration 296 296
Detachment of Device or Device Component 273 273
Material Deformation 259 259
Crack 246 246
Device Dislodged or Dislocated 244 244
Difficult to Advance 153 153
Premature Activation 121 121
Device Damaged Prior to Use 97 97
Fracture 82 82
Material Separation 70 70
Material Twisted/Bent 68 68
Mechanical Jam 59 59
Insufficient Information 58 58
Failure to Advance 57 57
Patient Device Interaction Problem 56 56
Positioning Failure 55 55
Defective Device 54 54
Physical Resistance/Sticking 50 50
Unintended Movement 47 47
Loose or Intermittent Connection 43 43
Migration or Expulsion of Device 43 43
Appropriate Term/Code Not Available 42 42
Entrapment of Device 41 41
Use of Device Problem 38 38
Material Split, Cut or Torn 37 37
Material Fragmentation 33 33
Difficult to Insert 25 25
Material Frayed 23 23
Device Contaminated During Manufacture or Shipping 20 20
Difficult to Remove 20 20
Delivered as Unsterile Product 17 17
Manufacturing, Packaging or Shipping Problem 17 17
Fitting Problem 16 16
Patient-Device Incompatibility 15 15
Packaging Problem 13 13
Positioning Problem 12 12
Output Problem 9 9
Loosening of Implant Not Related to Bone-Ingrowth 9 9
Unsealed Device Packaging 8 8
Product Quality Problem 7 7
Mechanical Problem 7 7
Device Slipped 6 6
Device Markings/Labelling Problem 6 6
Flaked 6 6
Unstable 6 6
Biocompatibility 6 6
Expulsion 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5613 5613
Insufficient Information 572 572
Unspecified Tissue Injury 403 403
No Consequences Or Impact To Patient 353 353
Foreign Body In Patient 336 336
Unspecified Infection 215 215
Failure of Implant 151 151
Not Applicable 100 100
Device Embedded In Tissue or Plaque 84 84
Pain 64 64
No Information 60 60
No Code Available 57 57
Perforation 55 55
No Known Impact Or Consequence To Patient 54 54
Injury 51 51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Rupture 40 40
Tissue Damage 35 35
Swelling/ Edema 34 34
Nerve Damage 34 34
Hypersensitivity/Allergic reaction 32 32
Foreign Body Reaction 31 31
Inflammation 28 28
Joint Laxity 21 21
Impaired Healing 18 18
Loss of Range of Motion 16 16
No Patient Involvement 15 15
Post Operative Wound Infection 14 14
Damage to Ligament(s) 14 14
Fluid Discharge 12 12
Abscess 11 11
Hemorrhage/Bleeding 11 11
Synovitis 9 9
Adhesion(s) 8 8
Sepsis 8 8
Discomfort 8 8
Purulent Discharge 7 7
Cyst(s) 7 7
Muscle/Tendon Damage 7 7
Reaction 7 7
Rash 7 7
Joint Dislocation 6 6
Osteolysis 6 6
Swelling 6 6
Bone Fracture(s) 5 5
Local Reaction 5 5
Staphylococcus Aureus 5 5
Thrombosis/Thrombus 5 5
Hematoma 4 4
Implant Pain 4 4

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 Smith & Nephew, Inc. II Apr-29-2021
4 Smith & Nephew, Inc. II Oct-21-2020
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