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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthopaedic surgical planning and instrument guides
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Definition As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.
Product CodePBF
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
3D LIFEPRINTS UK LTD.
  SUBSTANTIALLY EQUIVALENT 1
3D SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
3D-SIDE SA
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTERMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDCAD
  SUBSTANTIALLY EQUIVALENT 2
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 3
REDPOINT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 12 12
2022 53 53
2023 47 47
2024 34 34
2025 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 100 100
Use of Device Problem 58 58
Insufficient Information 4 4
Patient Device Interaction Problem 2 2
Appropriate Term/Code Not Available 2 2
Unstable 1 1
Device Ingredient or Reagent Problem 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Unintended Movement 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Failure to Align 1 1
Inadequacy of Device Shape and/or Size 1 1
Fracture 1 1
Device Dislodged or Dislocated 1 1
Improper or Incorrect Procedure or Method 1 1
Application Program Problem: Power Calculation Error 1 1
Loss of Osseointegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Osseointegration 67 67
Unspecified Infection 33 33
Joint Dislocation 24 24
Bacterial Infection 12 12
Joint Laxity 11 11
No Clinical Signs, Symptoms or Conditions 6 6
Unequal Limb Length 6 6
Pain 6 6
Bone Fracture(s) 5 5
Insufficient Information 4 4
Failure of Implant 2 2
Arthralgia 1 1
Unspecified Musculoskeletal problem 1 1
Skin Inflammation/ Irritation 1 1
Cyst(s) 1 1
Hematoma 1 1
Implant Pain 1 1
Foreign Body In Patient 1 1
Osteomyelitis 1 1
Loss of Range of Motion 1 1
Osteolysis 1 1
Unspecified Tissue Injury 1 1
Ambulation Difficulties 1 1
Device Embedded In Tissue or Plaque 1 1

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