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TPLC
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show TPLC since
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Device
impactor
Product Code
HWA
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
89
89
2015
112
112
2016
857
857
2017
1404
1404
2018
1609
1609
2019
1550
1550
2020
1477
1477
2021
2006
2006
2022
2086
2086
2023
2245
2245
2024
660
660
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
10230
10230
Crack
1240
1240
Naturally Worn
849
849
Fracture
785
785
Device-Device Incompatibility
647
647
Material Twisted/Bent
337
337
Material Deformation
204
204
Scratched Material
194
194
Contamination /Decontamination Problem
177
177
Appropriate Term/Code Not Available
166
166
Material Integrity Problem
120
120
Mechanical Jam
106
106
No Apparent Adverse Event
85
85
Adverse Event Without Identified Device or Use Problem
75
75
Detachment of Device or Device Component
71
71
Component Missing
57
57
Unintended Movement
54
54
Loose or Intermittent Connection
53
53
Material Fragmentation
42
42
Connection Problem
40
40
Failure to Disconnect
40
40
Insufficient Information
39
39
Entrapment of Device
34
34
Difficult to Remove
31
31
Illegible Information
31
31
Disassembly
30
30
Mechanical Problem
29
29
Device Operates Differently Than Expected
25
25
Device Contamination with Chemical or Other Material
25
25
Physical Resistance/Sticking
24
24
Material Discolored
20
20
Detachment Of Device Component
20
20
Dull, Blunt
16
16
Device Slipped
15
15
Fitting Problem
13
13
Sticking
13
13
Bent
13
13
Corroded
9
9
Use of Device Problem
9
9
Structural Problem
9
9
Device Dislodged or Dislocated
9
9
Compatibility Problem
8
8
Device Damaged by Another Device
8
8
Manufacturing, Packaging or Shipping Problem
8
8
Defective Device
7
7
Device Reprocessing Problem
7
7
Off-Label Use
6
6
Separation Failure
6
6
Device Issue
6
6
Device Damaged Prior to Use
6
6
Improper or Incorrect Procedure or Method
5
5
Difficult to Insert
5
5
Failure To Adhere Or Bond
5
5
Component Falling
5
5
Deformation Due to Compressive Stress
5
5
Positioning Problem
5
5
Material Split, Cut or Torn
4
4
Separation Problem
4
4
Degraded
4
4
Flaked
4
4
Defective Component
4
4
Problem with Sterilization
3
3
Material Separation
3
3
Device Difficult to Setup or Prepare
3
3
Device Or Device Fragments Location Unknown
3
3
Delivered as Unsterile Product
3
3
Material Disintegration
2
2
Migration or Expulsion of Device
2
2
Failure to Cut
2
2
Material Rupture
2
2
Device Inoperable
2
2
Failure to Clean Adequately
2
2
Device Difficult to Maintain
2
2
Osseointegration Problem
2
2
Split
2
2
Device Disinfection Or Sterilization Issue
2
2
Device Operational Issue
2
2
Material Distortion
2
2
Material Protrusion/Extrusion
1
1
Device Contaminated During Manufacture or Shipping
1
1
Expulsion
1
1
Mechanics Altered
1
1
Therapeutic or Diagnostic Output Failure
1
1
Device Handling Problem
1
1
Missing Test Results
1
1
Noise, Audible
1
1
Patient Device Interaction Problem
1
1
Explosion
1
1
Missing Information
1
1
Difficult or Delayed Separation
1
1
Device Fell
1
1
Unstable
1
1
Metal Shedding Debris
1
1
Solder Joint Fracture
1
1
Residue After Decontamination
1
1
Retraction Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Failure to Align
1
1
Dent in Material
1
1
Loss of Osseointegration
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6785
6785
No Consequences Or Impact To Patient
4337
4337
No Information
1181
1181
No Known Impact Or Consequence To Patient
1082
1082
Insufficient Information
417
417
No Code Available
227
227
No Patient Involvement
140
140
Not Applicable
110
110
Foreign Body In Patient
52
52
Device Embedded In Tissue or Plaque
33
33
Sedation
12
12
Pain
8
8
Injury
7
7
Unspecified Infection
7
7
Failure of Implant
4
4
Bone Fracture(s)
3
3
Reaction
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Inadequate Osseointegration
2
2
Osteopenia/ Osteoporosis
1
1
Limited Mobility Of The Implanted Joint
1
1
Patient Problem/Medical Problem
1
1
Unspecified Musculoskeletal problem
1
1
Needle Stick/Puncture
1
1
Non-union Bone Fracture
1
1
Joint Disorder
1
1
Thrombosis
1
1
Tissue Damage
1
1
Hematoma
1
1
Oversedation
1
1
Host-Tissue Reaction
1
1
Ossification
1
1
Eye Injury
1
1
Foreign Body Reaction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Jan-30-2012
2
Encore Medical, Lp
II
Mar-08-2017
3
Encore Medical, Lp
II
Oct-30-2015
4
Enztec Limited
II
Jan-24-2020
5
Exactech, Inc.
II
Jun-30-2023
6
Exactech, Inc.
II
Sep-10-2019
7
Greatbatch Medical
I
Nov-29-2016
8
Greatbatch Medical
I
Mar-06-2014
9
SpineFrontier, Inc.
II
Jun-05-2013
10
Stryker Howmedica Osteonics Corp.
II
Oct-07-2016
11
Stryker Howmedica Osteonics Corp.
II
Dec-27-2013
12
Stryker Howmedica Osteonics Corp.
II
Aug-27-2009
13
XTANT Medical
II
Jul-04-2020
14
Zimmer Biomet, Inc.
II
Feb-14-2018
15
Zimmer, Inc.
II
Nov-24-2014
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