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TPLC
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show TPLC since
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Device
gauge, depth
Product Code
HTJ
Regulation Number
888.4300
Device Class
1
MDR Year
MDR Reports
MDR Events
2016
178
178
2017
82
82
2018
104
104
2019
196
196
2020
354
354
2021
403
403
2022
316
316
2023
376
376
2024
252
252
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1320
1320
Material Deformation
437
437
Mechanical Jam
129
129
Device-Device Incompatibility
74
74
Incorrect Measurement
67
67
Fracture
42
42
Material Fragmentation
41
41
Use of Device Problem
36
36
Material Twisted/Bent
35
35
Component Missing
35
35
Detachment of Device or Device Component
28
28
Naturally Worn
25
25
Device Operates Differently Than Expected
25
25
Mechanical Problem
23
23
Material Integrity Problem
20
20
Illegible Information
17
17
Bent
16
16
Appropriate Term/Code Not Available
11
11
Device Slipped
9
9
Sticking
8
8
Entrapment of Device
8
8
No Apparent Adverse Event
7
7
Material Discolored
7
7
Crack
7
7
Fitting Problem
6
6
Defective Device
5
5
Failure to Cut
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Failure to Align
4
4
Degraded
4
4
Difficult to Remove
4
4
Device Reprocessing Problem
4
4
Particulates
3
3
Output Problem
3
3
Device Markings/Labelling Problem
3
3
Material Separation
3
3
Separation Failure
2
2
Unintended Movement
2
2
Misassembled
2
2
Calibration Problem
2
2
Difficult To Position
2
2
Improper or Incorrect Procedure or Method
1
1
Dull, Blunt
1
1
Detachment Of Device Component
1
1
Component Falling
1
1
Noise, Audible
1
1
Corroded
1
1
Physical Resistance/Sticking
1
1
Insufficient Information
1
1
Device Fell
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1334
1334
No Patient Involvement
379
379
No Consequences Or Impact To Patient
320
320
No Known Impact Or Consequence To Patient
131
131
Insufficient Information
66
66
No Code Available
22
22
No Information
16
16
Foreign Body In Patient
11
11
Not Applicable
3
3
Device Embedded In Tissue or Plaque
3
3
Failure of Implant
2
2
Injury
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Pneumothorax
1
1
Bone Fracture(s)
1
1
Blood Loss
1
1
Loss of Range of Motion
1
1
Laceration(s)
1
1
Sedation
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Zimmer Biomet, Inc.
II
Jul-04-2019
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