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TPLC
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Device
apparatus, traction, non-powered
Product Code
HST
Regulation Number
888.5850
Device Class
1
MDR Year
MDR Reports
MDR Events
2017
20
20
2018
25
25
2019
32
32
2020
37
37
2021
40
40
2022
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
28
28
Device-Device Incompatibility
17
17
Adverse Event Without Identified Device or Use Problem
16
16
Positioning Failure
11
11
Unintended Movement
10
10
Unstable
9
9
Device Operates Differently Than Expected
9
9
Material Twisted/Bent
8
8
Positioning Problem
7
7
Mechanical Jam
6
6
Detachment Of Device Component
6
6
Physical Resistance/Sticking
5
5
Mechanical Problem
5
5
Use of Device Problem
5
5
Detachment of Device or Device Component
3
3
Device Slipped
3
3
Insufficient Information
3
3
Material Deformation
3
3
Fracture
3
3
Material Separation
2
2
Failure To Adhere Or Bond
2
2
Appropriate Term/Code Not Available
2
2
Degraded
2
2
Therapeutic or Diagnostic Output Failure
2
2
Failure to Align
2
2
Loose or Intermittent Connection
2
2
Device Markings/Labelling Problem
2
2
Device Unsafe to Use in Environment
1
1
Electromagnetic Compatibility Problem
1
1
Connection Problem
1
1
Naturally Worn
1
1
Physical Property Issue
1
1
Crack
1
1
Material Integrity Problem
1
1
Device Fell
1
1
Peeled/Delaminated
1
1
Sticking
1
1
Fitting Problem
1
1
Inadequate or Insufficient Training
1
1
Patient-Device Incompatibility
1
1
Material Protrusion/Extrusion
1
1
Material Fragmentation
1
1
Material Too Rigid or Stiff
1
1
Patient Device Interaction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
51
51
No Clinical Signs, Symptoms or Conditions
49
49
No Consequences Or Impact To Patient
22
22
No Patient Involvement
15
15
No Code Available
8
8
Pain
4
4
Foreign Body In Patient
3
3
Unspecified Infection
2
2
Laceration(s)
2
2
Nerve Damage
2
2
Injury
2
2
Fall
2
2
Insufficient Information
2
2
Device Embedded In Tissue or Plaque
1
1
No Information
1
1
Head Injury
1
1
Abrasion
1
1
Eye Injury
1
1
Loss of Range of Motion
1
1
Swelling
1
1
Visual Impairment
1
1
Visual Disturbances
1
1
Non-union Bone Fracture
1
1
Numbness
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Allen Medical Systems, Inc.
II
Feb-14-2017
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