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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
Bone Fracture(s) 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 4 4
Device Embedded In Tissue or Plaque 4 4
Pain 3 3
Joint Laxity 2 2
Failure of Implant 2 2
Unequal Limb Length 2 2
Unspecified Musculoskeletal problem 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Tissue Injury 1 1
Implant Pain 1 1
Osteomyelitis 1 1
No Code Available 1 1
Osteolysis 1 1
Ambulation Difficulties 1 1
Foreign Body In Patient 1 1
Loss of Range of Motion 1 1
Arthralgia 1 1
Hematoma 1 1
Cyst(s) 1 1

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