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TPLC
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show TPLC since
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Device
appliance, fixation, nail/blade/plate combination, multiple component, metal composite
Product Code
LXT
Regulation Number
888.3030
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
19
19
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
57
57
Mechanical Problem
48
48
Adverse Event Without Identified Device or Use Problem
47
47
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
Device-Device Incompatibility
13
13
Migration or Expulsion of Device
12
12
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
Connection Problem
6
6
Device Contamination with Chemical or Other Material
6
6
Fitting Problem
6
6
Component Missing
6
6
Device Markings/Labelling Problem
5
5
Improper or Incorrect Procedure or Method
5
5
Corroded
5
5
Positioning Problem
5
5
Material Deformation
5
5
Device Packaging Compromised
5
5
Unsealed Device Packaging
4
4
Detachment Of Device Component
4
4
Tear, Rip or Hole in Device Packaging
4
4
Incorrect Device Or Component Shipped
4
4
Loose or Intermittent Connection
3
3
Mechanical Jam
3
3
Material Integrity Problem
3
3
Material Fragmentation
3
3
Delivered as Unsterile Product
3
3
Inadequacy of Device Shape and/or Size
2
2
Out-Of-Box Failure
2
2
Positioning Failure
2
2
Difficult to Remove
2
2
Unstable
2
2
Bent
2
2
Shipping Damage or Problem
2
2
Defective Component
2
2
Material Erosion
2
2
Separation Failure
2
2
Unintended Movement
2
2
Material Too Rigid or Stiff
1
1
Material Twisted/Bent
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 Clinical Signs, Symptoms or Conditions
38
38
No Information
30
30
Failure of Implant
25
25
No Consequences Or Impact To Patient
20
20
Non-union Bone Fracture
19
19
Unspecified Infection
15
15
Bone Fracture(s)
7
7
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
Impaired Healing
5
5
Insufficient Information
4
4
Tissue Damage
4
4
Inflammation
3
3
Post Operative Wound Infection
3
3
Irritation
3
3
Loss of Range of Motion
3
3
Injury
2
2
Complaint, Ill-Defined
2
2
Nerve Damage
2
2
Swelling
2
2
Fall
2
2
Unspecified Tissue Injury
2
2
Disability
1
1
Limited Mobility Of The Implanted Joint
1
1
Osteopenia/ Osteoporosis
1
1
Ossification
1
1
Neurological Deficit/Dysfunction
1
1
Skin Irritation
1
1
Muscular Rigidity
1
1
Discomfort
1
1
Osteolysis
1
1
Numbness
1
1
Wound Dehiscence
1
1
Sedation
1
1
Fluid Discharge
1
1
Skin Infection
1
1
Physical Asymmetry
1
1
Hemorrhage/Bleeding
1
1
Patient Problem/Medical Problem
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
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