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TPLC
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show TPLC since
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2024
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Device
wrench
Product Code
HXC
Regulation Number
888.4540
Device Class
1
Premarket Reviews
Manufacturer
Decision
GAUTHIER BIOMEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
18
18
2015
34
34
2016
100
100
2017
118
118
2018
111
111
2019
154
154
2020
142
142
2021
160
160
2022
143
143
2023
145
145
2024
81
81
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
311
311
Calibration Problem
237
237
Device-Device Incompatibility
115
115
Fracture
111
111
Mechanical Problem
78
78
Naturally Worn
66
66
Appropriate Term/Code Not Available
50
50
Material Deformation
49
49
Material Twisted/Bent
38
38
Mechanical Jam
34
34
Crack
28
28
Material Integrity Problem
27
27
Device Operates Differently Than Expected
25
25
Component Missing
24
24
Detachment of Device or Device Component
15
15
Bent
14
14
Scratched Material
14
14
Physical Resistance/Sticking
11
11
Unintended Movement
11
11
Corroded
10
10
Disassembly
10
10
Loose or Intermittent Connection
9
9
Failure to Cut
9
9
Output above Specifications
8
8
Failure to Calibrate
7
7
Output Problem
7
7
Material Torqued
6
6
Adverse Event Without Identified Device or Use Problem
6
6
Difficult to Remove
5
5
Use of Device Problem
5
5
Device Inoperable
4
4
Material Fragmentation
3
3
Structural Problem
3
3
Connection Problem
3
3
Entrapment of Device
3
3
Component or Accessory Incompatibility
3
3
Sticking
3
3
Illegible Information
3
3
Detachment Of Device Component
2
2
Output below Specifications
2
2
Separation Failure
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Failure to Disconnect
2
2
Improper or Incorrect Procedure or Method
2
2
Device Issue
2
2
Failure To Adhere Or Bond
2
2
Fitting Problem
2
2
Compatibility Problem
2
2
Insufficient Information
2
2
Unstable
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
517
517
No Consequences Or Impact To Patient
240
240
No Known Impact Or Consequence To Patient
180
180
No Patient Involvement
107
107
No Information
78
78
Insufficient Information
41
41
No Code Available
28
28
Not Applicable
14
14
Foreign Body In Patient
8
8
Injury
7
7
Sedation
7
7
Device Embedded In Tissue or Plaque
4
4
Failure of Implant
3
3
Bone Fracture(s)
2
2
Spinal Column Injury
2
2
Patient Problem/Medical Problem
1
1
Complaint, Ill-Defined
1
1
Tissue Damage
1
1
Vertebral Fracture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap, Inc.
II
Aug-03-2015
2
Biomet Spine, LLC
II
Apr-20-2015
3
Bradshaw Medical Inc.
II
May-10-2016
4
DePuy Spine, Inc.
II
Jan-16-2013
5
New Standard Device Inc
II
Jun-21-2022
6
Orthofix, Inc
II
Feb-11-2016
7
Zimmer Inc.
II
Mar-04-2009
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