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 3 3

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
Difficult to Insert 17 17
Insufficient Information 17 17
Fracture 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 10 10
Crack 9 9
Device Contaminated During Manufacture or Shipping 8 8
Device Operates Differently Than Expected 8 8
Physical Property Issue 7 7
Device Slipped 7 7
Device Contamination with Chemical or Other Material 6 6
Fitting Problem 6 6
Component Missing 6 6
Connection Problem 6 6
Corroded 5 5
Improper or Incorrect Procedure or Method 5 5
Material Deformation 5 5
Device Packaging Compromised 5 5
Positioning Problem 5 5
Device Markings/Labelling Problem 5 5
Unsealed Device Packaging 4 4
Detachment Of Device Component 4 4
Incorrect Device Or Component Shipped 4 4
Tear, Rip or Hole in Device Packaging 4 4
Material Integrity Problem 3 3
Delivered as Unsterile Product 3 3
Mechanical Jam 3 3
Material Fragmentation 3 3
Loose or Intermittent Connection 3 3
Material Erosion 2 2
Positioning Failure 2 2
Separation Failure 2 2
Out-Of-Box Failure 2 2
Unintended Movement 2 2
Inadequacy of Device Shape and/or Size 2 2
Shipping Damage or Problem 2 2
Unstable 2 2
Defective Component 2 2
Bent 2 2
Difficult to Remove 2 2
Material Twisted/Bent 1 1
Material Discolored 1 1
Failure To Adhere Or Bond 1 1
Device Contamination with Body Fluid 1 1
Device Abrasion From Instrument Or Another Object 1 1
Metal Shedding Debris 1 1
Device Dislodged or Dislocated 1 1
Loss of Osseointegration 1 1
Peeled/Delaminated 1 1
Material Separation 1 1
Device Damaged by Another Device 1 1
Material Too Rigid or Stiff 1 1
Scratched Material 1 1
Mechanics Altered 1 1
Image Orientation Incorrect 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Noise, Audible 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 25 25
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
-
-