Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 appliance, fixation, nail/blade/plate combination, multiple component, metal composite
Product CodeLXT
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ACUMED LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
NEW PARADIGM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 36 36
2015 35 35
2016 38 38
2017 66 66
2018 73 73
2019 40 40
2020 32 32
2021 24 24
2022 21 21
2023 18 18
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 57 57
Adverse Event Without Identified Device or Use Problem 44 44
Mechanical Problem 39 39
Packaging Problem 26 26
Manufacturing, Packaging or Shipping Problem 23 23
Insufficient Information 17 17
Fracture 17 17
Difficult to Insert 17 17
Migration 15 15
Malposition of Device 14 14
Appropriate Term/Code Not Available 13 13
Migration or Expulsion of Device 12 12
Device-Device Incompatibility 11 11
Crack 9 9
Device Operates Differently Than Expected 8 8
Device Contaminated During Manufacture or Shipping 8 8
Physical Property Issue 7 7
Device Slipped 7 7
Fitting Problem 6 6
Component Missing 6 6
Device Contamination with Chemical or Other Material 6 6
Connection Problem 6 6
Device Markings/Labelling Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Device Packaging Compromised 5 5
Material Deformation 5 5
Positioning Problem 5 5
Corroded 5 5
Detachment Of Device Component 4 4
Tear, Rip or Hole in Device Packaging 4 4
Unsealed Device Packaging 4 4
Incorrect Device Or Component Shipped 4 4
Material Integrity Problem 3 3
Mechanical Jam 3 3
Delivered as Unsterile Product 3 3
Loose or Intermittent Connection 3 3
Material Fragmentation 3 3
Bent 2 2
Material Erosion 2 2
Positioning Failure 2 2
Shipping Damage or Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Difficult to Remove 2 2
Out-Of-Box Failure 2 2
Defective Component 2 2
Unstable 2 2
Unintended Movement 2 2
Separation Failure 2 2
Device Damaged by Another Device 1 1
Device Dislodged or Dislocated 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Noise, Audible 1 1
Scratched Material 1 1
Metal Shedding Debris 1 1
Device Contamination with Body Fluid 1 1
Loss of Osseointegration 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Material Separation 1 1
Peeled/Delaminated 1 1
Material Discolored 1 1
Failure To Adhere Or Bond 1 1
Image Orientation Incorrect 1 1
Device Abrasion From Instrument Or Another Object 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 71 71
No Known Impact Or Consequence To Patient 61 61
No Code Available 61 61
Pain 43 43
No Information 30 30
No Clinical Signs, Symptoms or Conditions 26 26
Failure of Implant 25 25
No Consequences Or Impact To Patient 20 20
Non-union Bone Fracture 17 17
Unspecified Infection 14 14
Bone Fracture(s) 7 7
Impaired Healing 5 5
Device Embedded In Tissue or Plaque 5 5
Foreign Body In Patient 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Insufficient Information 4 4
Tissue Damage 4 4
Post Operative Wound Infection 3 3
Inflammation 3 3
Irritation 3 3
Loss of Range of Motion 3 3
Nerve Damage 2 2
Fall 2 2
Swelling 2 2
Complaint, Ill-Defined 2 2
Injury 2 2
Unspecified Tissue Injury 2 2
Physical Asymmetry 1 1
Skin Infection 1 1
Sedation 1 1
Disability 1 1
Osteolysis 1 1
Numbness 1 1
Patient Problem/Medical Problem 1 1
Osteopenia/ Osteoporosis 1 1
Limited Mobility Of The Implanted Joint 1 1
Fluid Discharge 1 1
Discomfort 1 1
Neurological Deficit/Dysfunction 1 1
Skin Irritation 1 1
Muscular Rigidity 1 1
Hemorrhage/Bleeding 1 1
Wound Dehiscence 1 1
Ossification 1 1
Arthritis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-08-2016
2 Biomet, Inc. II Apr-14-2015
3 CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. II Jun-28-2022
4 Zimmer Biomet, Inc. II Jan-10-2019
5 Zimmer Inc. II Jun-30-2009
-
-