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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
awl
Product Code
HWJ
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
16
16
2015
18
18
2016
24
24
2017
12
12
2018
11
11
2019
17
17
2020
9
9
2021
9
9
2022
10
10
2023
9
9
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
86
86
Material Fragmentation
11
11
Adverse Event Without Identified Device or Use Problem
11
11
Fracture
8
8
Failure to Cut
7
7
Material Deformation
6
6
Material Twisted/Bent
4
4
Detachment Of Device Component
4
4
Bent
3
3
Entrapment of Device
3
3
Contamination /Decontamination Problem
3
3
Device Operates Differently Than Expected
2
2
Device Contamination with Chemical or Other Material
2
2
Dull, Blunt
2
2
Difficult to Insert
2
2
Delivered as Unsterile Product
1
1
Unintended System Motion
1
1
Difficult to Remove
1
1
Material Separation
1
1
Sticking
1
1
Fitting Problem
1
1
Device Damaged Prior to Use
1
1
Failure to Align
1
1
Failure to Obtain Sample
1
1
Corroded
1
1
Crack
1
1
Material Integrity Problem
1
1
Device-Device Incompatibility
1
1
Detachment of Device or Device Component
1
1
Naturally Worn
1
1
Scratched Material
1
1
Torn Material
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
44
44
No Clinical Signs, Symptoms or Conditions
24
24
No Consequences Or Impact To Patient
22
22
No Code Available
16
16
No Patient Involvement
10
10
Foreign Body In Patient
7
7
Device Embedded In Tissue or Plaque
6
6
No Information
5
5
Insufficient Information
5
5
Injury
2
2
Hypoesthesia
1
1
Deformity/ Disfigurement
1
1
Fatigue
1
1
Nerve Damage
1
1
Paresis
1
1
Weakness
1
1
Unspecified Tissue Injury
1
1
Patient Problem/Medical Problem
1
1
Decreased Sensitivity
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Alphatec Spine, Inc.
II
Aug-28-2023
2
K2M, Inc
II
Apr-24-2020
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