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TPLC
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Device
instrument, manual, surgical, general use
Regulation Description
Manual surgical instrument for general use.
Product Code
MDM
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
244
244
2021
227
227
2022
182
182
2023
210
210
2024
507
507
2025
63
63
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
873
873
Physical Resistance/Sticking
52
52
Adverse Event Without Identified Device or Use Problem
50
50
Entrapment of Device
49
49
Difficult to Remove
48
48
Material Twisted/Bent
44
44
Fracture
38
38
Detachment of Device or Device Component
38
38
Material Fragmentation
32
32
Dull, Blunt
30
30
Corroded
19
19
Defective Device
19
19
Mechanical Jam
18
18
Appropriate Term/Code Not Available
17
17
Material Separation
16
16
Material Split, Cut or Torn
12
12
Mechanical Problem
11
11
Component Missing
11
11
Flaked
11
11
Fitting Problem
10
10
Material Deformation
10
10
Connection Problem
9
9
Device Damaged by Another Device
8
8
Failure to Disinfect
8
8
Activation, Positioning or Separation Problem
7
7
Naturally Worn
7
7
Failure to Cut
6
6
Crack
6
6
Use of Device Problem
6
6
Difficult to Open or Close
6
6
Patient Device Interaction Problem
6
6
Failure to Advance
6
6
Device Difficult to Maintain
5
5
Unintended Movement
5
5
Insufficient Information
5
5
Contamination /Decontamination Problem
5
5
Device Dislodged or Dislocated
4
4
Output Problem
4
4
Device-Device Incompatibility
4
4
Device Slipped
4
4
Inadequacy of Device Shape and/or Size
3
3
Difficult to Insert
3
3
Misfire
3
3
Incorrect Measurement
3
3
Device Damaged Prior to Use
3
3
Delivered as Unsterile Product
3
3
Separation Problem
3
3
Device Contamination with Chemical or Other Material
2
2
Product Quality Problem
2
2
Melted
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
693
693
Insufficient Information
266
266
Foreign Body In Patient
199
199
Device Embedded In Tissue or Plaque
83
83
No Known Impact Or Consequence To Patient
66
66
No Consequences Or Impact To Patient
41
41
No Patient Involvement
31
31
Failure of Implant
19
19
Injury
19
19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
13
13
Unspecified Infection
9
9
Pain
9
9
Bone Fracture(s)
9
9
No Information
7
7
Unspecified Tissue Injury
6
6
Perforation
6
6
No Code Available
5
5
Low Blood Pressure/ Hypotension
4
4
Swelling/ Edema
4
4
Pericardial Effusion
4
4
Cardiac Tamponade
3
3
Post Operative Wound Infection
3
3
Tissue Damage
3
3
Purulent Discharge
2
2
Inflammation
2
2
Discomfort
2
2
Metal Related Pathology
2
2
Not Applicable
2
2
Laceration(s)
2
2
Joint Laxity
2
2
Heart Block
2
2
Internal Organ Perforation
2
2
Synovitis
1
1
Edema
1
1
Obstruction/Occlusion
1
1
Hematoma
1
1
Sepsis
1
1
Exposure to Body Fluids
1
1
Muscular Rigidity
1
1
Loss of Range of Motion
1
1
Cardiogenic Shock
1
1
Joint Dislocation
1
1
Increased Appetite
1
1
Subluxation
1
1
Arthralgia
1
1
Hip Fracture
1
1
Perforation of Vessels
1
1
Hypoxia
1
1
Ulcer
1
1
Wound Dehiscence
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Applied Medical Resources Corp
II
Mar-27-2024
2
Arthrex, Inc.
II
Dec-08-2022
3
ENDO Pharmaceuticals Solutions, Inc.
II
Dec-30-2022
4
FlexDex Inc.
II
Jan-27-2022
5
MEDLINE INDUSTRIES, LP - Northfield
II
Apr-17-2025
6
MEDLINE INDUSTRIES, LP - Northfield
II
Mar-29-2024
7
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-06-2023
8
Sklar Instruments
II
Jan-16-2025
9
Technicality Inc.
II
Apr-02-2024
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