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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
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET SPORTS MEDICINE
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
CABLE FIX MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
CIRCUMFIX SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DALLEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DALLEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DSM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FIGURE 8 SURGICAL, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
FRONTIER MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
IMPLANET S.A.
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 1
KINAMED INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
KINAMED, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
NEOS SURGERY SL
  SUBSTANTIALLY EQUIVALENT 2
PIONEER SURGICAL TECHNOLOGY, INC
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
  SUBSTANTIALLY EQUIVALENT 3
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIC BREVETTI S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA)
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 223 223
2015 205 205
2016 223 223
2017 138 138
2018 182 182
2019 159 159
2020 124 124
2021 141 141
2022 134 134
2023 98 98
2024 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 377 377
Break 375 375
Device Operates Differently Than Expected 249 249
Mechanical Problem 189 189
Insufficient Information 90 90
Fracture 64 64
Device-Device Incompatibility 40 40
Failure To Adhere Or Bond 34 34
Device Slipped 29 29
Mechanical Jam 29 29
Migration 23 23
Unintended Movement 21 21
Migration or Expulsion of Device 21 21
Loose or Intermittent Connection 20 20
Material Deformation 19 19
Appropriate Term/Code Not Available 19 19
Sticking 16 16
Component Missing 15 15
Material Frayed 12 12
No Apparent Adverse Event 12 12
Device Dislodged or Dislocated 11 11
Bent 9 9
Crack 9 9
Difficult to Advance 8 8
Material Integrity Problem 7 7
Material Separation 7 7
Material Fragmentation 7 7
Device Difficult to Maintain 7 7
Failure to Cut 6 6
Detachment of Device or Device Component 6 6
Difficult to Open or Close 5 5
Device Handling Problem 5 5
Device Operational Issue 4 4
Device Issue 4 4
Dull, Blunt 4 4
Detachment Of Device Component 4 4
Corroded 4 4
Difficult to Remove 4 4
Difficult to Insert 3 3
Device Reprocessing Problem 3 3
Loss of or Failure to Bond 3 3
Entrapment of Device 3 3
Failure to Advance 3 3
Fitting Problem 3 3
Device Disinfection Or Sterilization Issue 3 3
Device Contamination with Chemical or Other Material 3 3
Inadequacy of Device Shape and/or Size 3 3
Patient Device Interaction Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Naturally Worn 2 2
Packaging Problem 2 2
Incorrect Device Or Component Shipped 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Protrusion/Extrusion 2 2
Patient-Device Incompatibility 2 2
Device Packaging Compromised 2 2
Defective Component 2 2
Failure to Osseointegrate 2 2
Use of Device Problem 2 2
Separation Failure 2 2
Defective Device 2 2
Loss of Osseointegration 2 2
Degraded 2 2
Material Disintegration 2 2
Difficult To Position 2 2
Device Difficult to Setup or Prepare 2 2
Material Rupture 2 2
Product Quality Problem 2 2
Device Appears to Trigger Rejection 2 2
Device Inoperable 2 2
Unraveled Material 1 1
Unstable 1 1
Off-Label Use 1 1
Delivered as Unsterile Product 1 1
Disassembly 1 1
Material Discolored 1 1
Disconnection 1 1
Device Expiration Issue 1 1
Failure to Charge 1 1
Component Falling 1 1
Contamination 1 1
Cut In Material 1 1
Tear, Rip or Hole in Device Packaging 1 1
Malposition of Device 1 1
Physical Resistance 1 1
Metal Shedding Debris 1 1
Shelf Life Exceeded 1 1
Improper or Incorrect Procedure or Method 1 1
Microbial Contamination of Device 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Device Markings/Labelling Problem 1 1
Material Distortion 1 1
Positioning Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Fail-Safe Mechanism 1 1
Mechanics Altered 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 Known Impact Or Consequence To Patient 333 333
No Clinical Signs, Symptoms or Conditions 215 215
Unspecified Infection 187 187
No Code Available 182 182
Pain 175 175
No Patient Involvement 158 158
No Consequences Or Impact To Patient 149 149
Non-union Bone Fracture 100 100
Failure of Implant 99 99
Injury 48 48
Bone Fracture(s) 46 46
Impaired Healing 44 44
No Information 36 36
Insufficient Information 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Wound Dehiscence 18 18
Post Operative Wound Infection 17 17
Reaction 16 16
Death 16 16
Inflammation 15 15
Fall 14 14
Device Embedded In Tissue or Plaque 14 14
Hypersensitivity/Allergic reaction 13 13
Hemorrhage/Bleeding 11 11
Joint Dislocation 11 11
Hematoma 9 9
Swelling 8 8
Loss of Range of Motion 7 7
Sepsis 7 7
Discomfort 7 7
Ambulation Difficulties 7 7
Foreign Body In Patient 7 7
Metal Related Pathology 7 7
Unspecified Tissue Injury 7 7
Not Applicable 6 6
Hip Fracture 6 6
Adhesion(s) 6 6
Edema 5 5
Irritation 5 5
Patient Problem/Medical Problem 5 5
Malunion of Bone 5 5
Bacterial Infection 4 4
Necrosis 4 4
Osteolysis 4 4
Tissue Damage 4 4
Joint Disorder 3 3
Arthritis 3 3
Burn(s) 2 2
Ossification 2 2
Abscess 2 2
Cellulitis 2 2
Infarction, Cerebral 2 2
Chest Pain 2 2
Ischemia 2 2
Inadequate Osseointegration 2 2
Osteopenia/ Osteoporosis 2 2
Limited Mobility Of The Implanted Joint 2 2
Fluid Discharge 2 2
Nerve Damage 2 2
Neurological Deficit/Dysfunction 2 2
Sedation 2 2
Disability 2 2
Toxicity 2 2
Joint Contracture 2 2
Swelling/ Edema 2 2
Muscle/Tendon Damage 1 1
Blister 1 1
Solid Tumour 1 1
Fibrosis 1 1
Balance Problems 1 1
Joint Laxity 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Synovitis 1 1
Blood Loss 1 1
Organ Dehiscence 1 1
Sudden Cardiac Death 1 1
Obstruction/Occlusion 1 1
Neck Pain 1 1
Laceration(s) 1 1
Damage to Ligament(s) 1 1
Muscular Rigidity 1 1
Nausea 1 1
Foreign Body Reaction 1 1
Granuloma 1 1
Headache 1 1
Cyst(s) 1 1
Purulent Discharge 1 1
Pulmonary Embolism 1 1
Abdominal Pain 1 1
Host-Tissue Reaction 1 1
Cardiac Arrest 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alto Development Corp II Oct-30-2019
2 EXP Pharmaceutical Services Corp II Jul-24-2015
3 PIONEER SURGICAL TECHNOLOGY, INC. II Jul-17-2014
4 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Jul-09-2015
5 Smith & Nephew Inc II Aug-10-2010
6 Synthes (USA) Products LLC II Nov-14-2015
7 Synthes (USA) Products LLC II Aug-27-2015
8 Synthes USA HQ, Inc. II Oct-30-2013
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