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TPLC
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show TPLC since
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Device
instrument, cutting, orthopedic
Product Code
HTZ
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
47
47
2019
109
109
2020
87
87
2021
229
229
2022
196
196
2023
157
157
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
277
277
Device-Device Incompatibility
193
193
Material Deformation
106
106
Naturally Worn
91
91
Material Twisted/Bent
42
42
Scratched Material
35
35
Mechanical Jam
32
32
Corroded
29
29
Physical Resistance/Sticking
22
22
Crack
21
21
Material Integrity Problem
18
18
Contamination /Decontamination Problem
14
14
Adverse Event Without Identified Device or Use Problem
13
13
Mechanical Problem
11
11
Detachment of Device or Device Component
10
10
Illegible Information
9
9
Activation, Positioning or Separation Problem
8
8
Failure to Cut
6
6
Difficult to Remove
5
5
Material Frayed
5
5
Loose or Intermittent Connection
4
4
Entrapment of Device
4
4
Appropriate Term/Code Not Available
4
4
Connection Problem
3
3
Patient-Device Incompatibility
2
2
Material Discolored
2
2
Use of Device Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Device Issue
2
2
Structural Problem
2
2
Failure to Disconnect
2
2
Device Damaged by Another Device
2
2
Sharp Edges
2
2
Unintended Movement
2
2
No Apparent Adverse Event
2
2
Positioning Problem
1
1
Component Missing
1
1
Material Separation
1
1
Device Slipped
1
1
Off-Label Use
1
1
Display Difficult to Read
1
1
Incorrect Measurement
1
1
Degraded
1
1
Device Operates Differently Than Expected
1
1
Difficult to Open or Close
1
1
Device Dislodged or Dislocated
1
1
Device Contamination with Chemical or Other Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
561
561
No Consequences Or Impact To Patient
163
163
Insufficient Information
31
31
No Patient Involvement
23
23
No Known Impact Or Consequence To Patient
17
17
No Code Available
15
15
Not Applicable
14
14
Foreign Body In Patient
3
3
Unspecified Tissue Injury
3
3
Pain
2
2
Post Operative Wound Infection
2
2
Hemorrhage/Bleeding
2
2
Unspecified Infection
2
2
Nerve Damage
1
1
Failure of Implant
1
1
Injury
1
1
Disability
1
1
Joint Dislocation
1
1
Spinal Cord Injury
1
1
Cerebrospinal Fluid Leakage
1
1
Paralysis
1
1
No Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Feb-13-2020
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