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TPLC
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show TPLC since
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Device
tap, bone
Regulation Description
Orthopedic manual surgical instrument.
Product Code
HWX
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
85
85
2021
91
91
2022
91
91
2023
84
84
2024
84
84
2025
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
188
188
Device-Device Incompatibility
150
150
Contamination /Decontamination Problem
39
39
Fracture
28
28
Entrapment of Device
12
12
Crack
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Material Fragmentation
6
6
Failure to Cut
5
5
Material Integrity Problem
5
5
Mechanical Jam
4
4
Dull, Blunt
3
3
Material Twisted/Bent
3
3
Appropriate Term/Code Not Available
3
3
Material Separation
3
3
Naturally Worn
2
2
Material Deformation
2
2
Use of Device Problem
2
2
Difficult to Remove
2
2
Material Split, Cut or Torn
2
2
No Apparent Adverse Event
2
2
Fitting Problem
1
1
Device Slipped
1
1
Illegible Information
1
1
Detachment of Device or Device Component
1
1
Device Contaminated During Manufacture or Shipping
1
1
Expulsion
1
1
Compatibility Problem
1
1
Separation Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
333
333
No Consequences Or Impact To Patient
42
42
Foreign Body In Patient
24
24
No Patient Involvement
24
24
Insufficient Information
18
18
No Known Impact Or Consequence To Patient
5
5
Bone Fracture(s)
4
4
Injury
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
No Code Available
2
2
Device Embedded In Tissue or Plaque
1
1
Not Applicable
1
1
Post Operative Wound Infection
1
1
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