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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
724
724
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
7556
7556
Crack
937
937
Naturally Worn
902
902
Device-Device Incompatibility
725
725
Fracture
553
553
Material Twisted/Bent
279
279
Material Deformation
273
273
Contamination /Decontamination Problem
202
202
Scratched Material
151
151
No Apparent Adverse Event
132
132
Material Integrity Problem
130
130
Mechanical Jam
76
76
Unintended Movement
70
70
Detachment of Device or Device Component
60
60
Adverse Event Without Identified Device or Use Problem
58
58
Illegible Information
39
39
Entrapment of Device
32
32
Failure to Disconnect
20
20
Mechanical Problem
20
20
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
Compatibility Problem
10
10
Difficult to Remove
9
9
Physical Resistance/Sticking
9
9
Structural Problem
9
9
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
Connection Problem
3
3
Difficult to Insert
3
3
Nonstandard Device
3
3
Material Separation
3
3
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
8200
8200
No Consequences Or Impact To Patient
1169
1169
Insufficient Information
1153
1153
No Code Available
162
162
No Known Impact Or Consequence To Patient
67
67
No Patient Involvement
40
40
Foreign Body In Patient
31
31
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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