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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
A&E MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ARTHREX, INC
  SUBSTANTIALLY EQUIVALENT 1
CABLE FIX MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
KINAMED, INCORPORATED
  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
SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 182 182
2019 159 159
2020 124 124
2021 141 141
2022 134 134
2023 92 92

Device Problems MDRs with this Device Problem Events in those MDRs
Break 219 219
Adverse Event Without Identified Device or Use Problem 210 210
Mechanical Problem 170 170
Fracture 35 35
Device-Device Incompatibility 35 35
Insufficient Information 35 35
Device Operates Differently Than Expected 22 22
Migration 21 21
Device Slipped 20 20
No Apparent Adverse Event 12 12
Material Frayed 8 8
Migration or Expulsion of Device 7 7
Appropriate Term/Code Not Available 7 7
Unintended Movement 6 6
Device Difficult to Maintain 6 6
Material Deformation 6 6
Material Separation 5 5
Failure to Cut 5 5
Loose or Intermittent Connection 3 3
Material Fragmentation 3 3
Entrapment of Device 3 3
Material Integrity Problem 3 3
Mechanical Jam 2 2
Patient Device Interaction Problem 2 2
Loss of or Failure to Bond 2 2
Device Appears to Trigger Rejection 2 2
Device Difficult to Setup or Prepare 2 2
Defective Component 2 2
Use of Device Problem 2 2
Failure to Osseointegrate 2 2
Device Dislodged or Dislocated 2 2
Patient-Device Incompatibility 2 2
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Device Contamination with Chemical or Other Material 1 1
Device Operational Issue 1 1
Improper or Incorrect Procedure or Method 1 1
Sticking 1 1
Component Missing 1 1
Device Issue 1 1
Defective Device 1 1
Malposition of Device 1 1
Product Quality Problem 1 1
Delivered as Unsterile Product 1 1
Difficult to Insert 1 1
Corroded 1 1
Crack 1 1
Degraded 1 1
Disconnection 1 1
Material Disintegration 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Device Handling Problem 1 1
Naturally Worn 1 1
No Fail-Safe Mechanism 1 1
Packaging Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 200 200
No Consequences Or Impact To Patient 123 123
No Code Available 106 106
Unspecified Infection 91 91
Pain 72 72
No Known Impact Or Consequence To Patient 52 52
Non-union Bone Fracture 51 51
Failure of Implant 41 41
No Patient Involvement 38 38
Injury 34 34
Bone Fracture(s) 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Death 15 15
Hypersensitivity/Allergic reaction 13 13
Wound Dehiscence 12 12
Post Operative Wound Infection 12 12
Hemorrhage/Bleeding 11 11
Inflammation 10 10
Fall 9 9
Insufficient Information 9 9
Hematoma 8 8
Impaired Healing 8 8
No Information 7 7
Metal Related Pathology 6 6
Unspecified Tissue Injury 6 6
Reaction 6 6
Joint Dislocation 6 6
Adhesion(s) 6 6
Edema 5 5
Hip Fracture 5 5
Not Applicable 5 5
Foreign Body In Patient 5 5
Patient Problem/Medical Problem 4 4
Ambulation Difficulties 4 4
Loss of Range of Motion 4 4
Bacterial Infection 3 3
Malunion of Bone 3 3
Swelling/ Edema 2 2
Fluid Discharge 2 2
Device Embedded In Tissue or Plaque 2 2
Joint Contracture 2 2
Ossification 2 2
Infarction, Cerebral 2 2
Nerve Damage 2 2
Obstruction/Occlusion 1 1
Joint Disorder 1 1
Sepsis 1 1
Tissue Damage 1 1
Irritation 1 1
Muscular Rigidity 1 1
Nausea 1 1
Necrosis 1 1
Chest Pain 1 1
Cyst(s) 1 1
Abscess 1 1
Burn(s) 1 1
Cardiac Arrest 1 1
Cellulitis 1 1
Joint Laxity 1 1
Fibrosis 1 1
Inadequate Osseointegration 1 1
Osteopenia/ Osteoporosis 1 1
Limited Mobility Of The Implanted Joint 1 1
Blister 1 1
Solid Tumour 1 1

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