• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device cerclage, fixation
Regulation Description Bone fixation cerclage.
Product CodeJDQ
Regulation Number 888.3010
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
DSM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FRONTIER MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 3
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH and CO. KG
  SUBSTANTIALLY EQUIVALENT 1
RTI SURGICAL, INC. (DBA RTI BIOLOGICS, INC.)
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 205 205
2016 223 223
2017 138 138
2018 182 182
2019 159 159
2020 82 82

Device Problems MDRs with this Device Problem Events in those MDRs
Break 219 219
Adverse Event Without Identified Device or Use Problem 209 209
Device Operates Differently Than Expected 196 196
Mechanical Problem 81 81
Insufficient Information 62 62
Fracture 45 45
Mechanical Jam 22 22
Unintended Movement 16 16
Failure To Adhere Or Bond 15 15
Loose or Intermittent Connection 15 15
Component Missing 15 15
Appropriate Term/Code Not Available 15 15
Device-Device Incompatibility 12 12
Sticking 11 11
No Apparent Adverse Event 11 11
Cable, Electrical 11 11
Migration or Expulsion of Device 10 10
Device Slipped 9 9
Device Dislodged or Dislocated 8 8
Difficult to Advance 8 8
Material Deformation 7 7
Device Difficult to Maintain 7 7
Bent 7 7
Material Frayed 6 6
Detachment of Device or Device Component 5 5
Device Handling Problem 5 5
Device Issue 4 4
Difficult to Open or Close 4 4
Device Operational Issue 4 4
Plate 4 4
Material Fragmentation 4 4
Material Separation 4 4
Corroded 4 4
Dull, Blunt 4 4
Material Integrity Problem 4 4
Migration 3 3
Failure to Advance 3 3
Difficult to Insert 3 3
Inadequacy of Device Shape and/or Size 3 3
Crack 3 3
Difficult to Remove 3 3
Use of Device Problem 2 2
Device Packaging Compromised 2 2
Packaging Problem 2 2
Loss of or Failure to Bond 2 2
Device Difficult to Setup or Prepare 2 2
Detachment Of Device Component 2 2
Fitting Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Incorrect Device Or Component Shipped 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Loss of Osseointegration 1 1
Connection Problem 1 1
Material Distortion 1 1
Device Subassembly 1 1
Positioning Problem 1 1
Contamination 1 1
Disconnection 1 1
Delivered as Unsterile Product 1 1
Product Quality Problem 1 1
Material Rupture 1 1
Guidewire 1 1
Unraveled Material 1 1
Unstable 1 1
Improper or Incorrect Procedure or Method 1 1
Off-Label Use 1 1
Shelf Life Exceeded 1 1
Degraded 1 1
Disassembly 1 1
Material Disintegration 1 1
Thread 1 1
Tip 1 1
No Fail-Safe Mechanism 1 1
Microbial Contamination of Device 1 1
Cut In Material 1 1
Physical Resistance 1 1
Failure to Cut 1 1
Defective Device 1 1
Activation, Positioning or SeparationProblem 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 246 246
No Code Available 158 158
No Patient Involvement 138 138
No Consequences Or Impact To Patient 134 134
Pain 104 104
Unspecified Infection 89 89
Non-union Bone Fracture 57 57
Failure of Implant 53 53
Injury 46 46
Impaired Healing 39 39
Bone Fracture(s) 38 38
No Information 29 29
Device Embedded In Tissue or Plaque 14 14
Reaction 13 13
Wound Dehiscence 11 11
Post Operative Wound Infection 10 10
Death 10 10
Hemorrhage/Bleeding 8 8
Inflammation 8 8
Swelling 7 7
Joint Dislocation 6 6
Sepsis 6 6
Discomfort 6 6
Not Applicable 6 6
Patient Problem/Medical Problem 5 5
Hematoma 5 5
Irritation 5 5
Ambulation Difficulties 5 5
Hypersensitivity/Allergic reaction 4 4
Edema 4 4
Necrosis 4 4
Joint Disorder 3 3
Fall 3 3
Arthritis 3 3
Ischemia 2 2
Neurological Deficit/Dysfunction 2 2
Foreign Body In Patient 2 2
Tissue Damage 2 2
Infarction, Cerebral 2 2
Chest Pain 2 2
Purulent Discharge 1 1
Ossification 1 1
Abdominal Pain 1 1
Adhesion(s) 1 1
Bacterial Infection 1 1
Cardiac Arrest 1 1
Synovitis 1 1
Laceration(s) 1 1
Nausea 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Obstruction/Occlusion 1 1
Disability 1 1
Fibrosis 1 1
Blood Loss 1 1
Inadequate Osseointegration 1 1
Limited Mobility Of The Implanted Joint 1 1
Loss of Range of Motion 1 1
Burn(s) 1 1
Cyst(s) 1 1
Abscess 1 1
Osteolysis 1 1
Sudden Cardiac Death 1 1
Hip Fracture 1 1
Sedation 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 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Jul-09-2015
4 Synthes (USA) Products LLC II Nov-14-2015
5 Synthes (USA) Products LLC II Aug-27-2015
-
-