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TPLC
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Device
impactor
Regulation Description
Orthopedic manual surgical instrument.
Product Code
HWA
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
1477
1477
2021
2006
2006
2022
2086
2086
2023
2240
2240
2024
2009
2009
2025
395
395
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
7320
7320
Crack
911
911
Naturally Worn
900
900
Device-Device Incompatibility
692
692
Fracture
546
546
Material Twisted/Bent
279
279
Material Deformation
235
235
Contamination /Decontamination Problem
200
200
Scratched Material
148
148
Material Integrity Problem
130
130
No Apparent Adverse Event
120
120
Mechanical Jam
75
75
Unintended Movement
67
67
Adverse Event Without Identified Device or Use Problem
58
58
Detachment of Device or Device Component
57
57
Illegible Information
39
39
Entrapment of Device
32
32
Failure to Disconnect
19
19
Mechanical Problem
18
18
Material Discolored
17
17
Manufacturing, Packaging or Shipping Problem
16
16
Component Missing
15
15
Material Fragmentation
11
11
Loose or Intermittent Connection
11
11
Device Slipped
11
11
Difficult to Remove
9
9
Physical Resistance/Sticking
9
9
Structural Problem
9
9
Compatibility Problem
8
8
Off-Label Use
7
7
Improper or Incorrect Procedure or Method
7
7
Corroded
6
6
Use of Device Problem
6
6
Appropriate Term/Code Not Available
6
6
Deformation Due to Compressive Stress
5
5
Insufficient Information
4
4
Solder Joint Fracture
4
4
Difficult to Insert
3
3
Nonstandard Device
3
3
Material Separation
3
3
Connection Problem
2
2
Flaked
2
2
Dull, Blunt
2
2
Mechanics Altered
2
2
Device Damaged by Another Device
2
2
Failure to Cut
2
2
Fitting Problem
2
2
Device Handling Problem
1
1
Packaging Problem
1
1
Missing Test Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7974
7974
No Consequences Or Impact To Patient
1169
1169
Insufficient Information
1048
1048
No Code Available
162
162
No Known Impact Or Consequence To Patient
67
67
No Patient Involvement
40
40
Foreign Body In Patient
30
30
Not Applicable
21
21
Pain
4
4
Unspecified Infection
3
3
Failure of Implant
3
3
Device Embedded In Tissue or Plaque
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
No Information
2
2
Bone Fracture(s)
2
2
Hematoma
1
1
Osteopenia/ Osteoporosis
1
1
Needle Stick/Puncture
1
1
Unspecified Tissue Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Enztec Limited
II
Jan-24-2020
2
Exactech, Inc.
II
Jun-30-2023
3
INCIPIO DEVICES
II
Nov-25-2024
4
XTANT Medical
II
Jul-04-2020
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