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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
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 SYSTEMS, INC.
  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
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 2
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDCAD
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 1
REDPOINT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2018 2 2
2019 1 1
2020 2 2
2021 12 12
2022 53 53
2023 47 47
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 58 58
Use of Device Problem 57 57
Break 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 2 2
Patient Device Interaction Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Fracture 1 1
Inadequacy of Device Shape and/or Size 1 1
Unstable 1 1
Fitting Problem 1 1
Loss of Osseointegration 1 1
Failure to Align 1 1
Device Or Device Fragments Location Unknown 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Osseointegration 62 62
Unspecified Infection 22 22
Joint Dislocation 13 13
Bacterial Infection 12 12
No Clinical Signs, Symptoms or Conditions 5 5
Bone Fracture(s) 5 5
Device Embedded In Tissue or Plaque 4 4
Insufficient Information 4 4
Pain 3 3
Unequal Limb Length 2 2
Joint Laxity 2 2
Failure of Implant 2 2
Unspecified Musculoskeletal problem 1 1
Foreign Body In Patient 1 1
Arthralgia 1 1
Unspecified Tissue Injury 1 1
No Code Available 1 1
Implant Pain 1 1
Osteomyelitis 1 1
Cyst(s) 1 1
Loss of Range of Motion 1 1
Skin Inflammation/ Irritation 1 1
Hematoma 1 1
Osteolysis 1 1
Ambulation Difficulties 1 1

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