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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cerclage, fixation
Product CodeJDQ
Regulation Number 888.3010
Device Class 2


Premarket Reviews
ManufacturerDecision
A&E MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC
  SUBSTANTIALLY EQUIVALENT 1
CIRCUMFIX SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
NEOS SURGERY SL
  SUBSTANTIALLY EQUIVALENT 2
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
  SUBSTANTIALLY EQUIVALENT 2
RIVERPOINT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 159 159
2020 124 124
2021 141 141
2022 134 134
2023 98 98
2024 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Break 193 193
Adverse Event Without Identified Device or Use Problem 173 173
Mechanical Problem 163 163
Device-Device Incompatibility 36 36
Fracture 28 28
Migration 23 23
Device Slipped 21 21
Insufficient Information 17 17
No Apparent Adverse Event 12 12
Material Deformation 12 12
Material Frayed 8 8
Crack 7 7
Device Difficult to Maintain 6 6
Migration or Expulsion of Device 5 5
Failure to Cut 5 5
Material Separation 4 4
Appropriate Term/Code Not Available 4 4
Material Fragmentation 3 3
Entrapment of Device 3 3
Material Integrity Problem 3 3
Patient-Device Incompatibility 2 2
Defective Component 2 2
Use of Device Problem 2 2
Failure to Osseointegrate 2 2
Degraded 2 2
Product Quality Problem 2 2
Device Appears to Trigger Rejection 2 2
Patient Device Interaction Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Device Handling Problem 1 1
Packaging Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Delivered as Unsterile Product 1 1
Device Difficult to Setup or Prepare 1 1
Material Disintegration 1 1
Corroded 1 1
Loss of or Failure to Bond 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Loss of Osseointegration 1 1
Defective Device 1 1
Malposition of Device 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
No Fail-Safe Mechanism 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 216 216
No Consequences Or Impact To Patient 100 100
No Code Available 85 85
Unspecified Infection 75 75
Pain 55 55
Non-union Bone Fracture 46 46
Failure of Implant 39 39
Insufficient Information 28 28
No Patient Involvement 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Bone Fracture(s) 20 20
No Known Impact Or Consequence To Patient 17 17
Injury 15 15
Hypersensitivity/Allergic reaction 12 12
Post Operative Wound Infection 12 12
Inflammation 10 10
Fall 9 9
Wound Dehiscence 7 7
Metal Related Pathology 7 7
Unspecified Tissue Injury 7 7
Reaction 6 6
Adhesion(s) 6 6
Death 6 6
Hematoma 6 6
Edema 5 5
Hip Fracture 5 5
Impaired Healing 5 5
Foreign Body In Patient 5 5
Malunion of Bone 5 5
Loss of Range of Motion 4 4
Joint Dislocation 3 3
Bacterial Infection 3 3
Hemorrhage/Bleeding 3 3
Not Applicable 3 3
No Information 2 2
Patient Problem/Medical Problem 2 2
Fluid Discharge 2 2
Joint Contracture 2 2
Swelling/ Edema 2 2
Ossification 2 2
Cellulitis 2 2
Nerve Damage 2 2
Osteolysis 1 1
Inadequate Osseointegration 1 1
Osteopenia/ Osteoporosis 1 1
Limited Mobility Of The Implanted Joint 1 1
Sepsis 1 1
Tissue Damage 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Cyst(s) 1 1
Abscess 1 1
Burn(s) 1 1
Foreign Body Reaction 1 1
Muscular Rigidity 1 1
Necrosis 1 1
Balance Problems 1 1
Joint Laxity 1 1
Muscle/Tendon Damage 1 1
Blister 1 1
Solid Tumour 1 1
Device Embedded In Tissue or Plaque 1 1
Fibrosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alto Development Corp II Oct-30-2019
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