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TPLC
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Device
expander, surgical, skin graft
Regulation Description
Manual surgical instrument for general use.
Product Code
FZW
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
486
486
2021
554
554
2022
510
510
2023
606
606
2024
443
443
2025
206
206
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Cut
1343
1343
Material Twisted/Bent
607
607
Physical Resistance/Sticking
486
486
Appropriate Term/Code Not Available
186
186
Material Deformation
98
98
Naturally Worn
81
81
Patient Device Interaction Problem
62
62
Mechanical Problem
59
59
Break
55
55
Mechanical Jam
48
48
Insufficient Information
48
48
Fitting Problem
47
47
Calibration Problem
35
35
Material Integrity Problem
31
31
Component Missing
28
28
Dull, Blunt
25
25
Difficult to Remove
25
25
Delivered as Unsterile Product
20
20
Failure to Advance
16
16
Positioning Problem
15
15
Activation, Positioning or Separation Problem
12
12
Retraction Problem
12
12
Loose or Intermittent Connection
11
11
Output Problem
11
11
Activation Failure
11
11
No Apparent Adverse Event
9
9
Detachment of Device or Device Component
9
9
Difficult to Open or Close
7
7
Material Discolored
7
7
Activation Problem
6
6
Device Slipped
5
5
Device Markings/Labelling Problem
5
5
Connection Problem
5
5
Difficult to Advance
5
5
Defective Device
5
5
Misassembled
5
5
Degraded
5
5
Failure to Align
5
5
Electrical /Electronic Property Problem
4
4
Dent in Material
4
4
Material Too Rigid or Stiff
4
4
Noise, Audible
3
3
Failure to Disconnect
3
3
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Packaging Problem
3
3
Positioning Failure
2
2
Unstable
2
2
Structural Problem
2
2
Material Split, Cut or Torn
2
2
Flaked
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2168
2168
No Patient Involvement
305
305
No Consequences Or Impact To Patient
207
207
Insufficient Information
92
92
No Known Impact Or Consequence To Patient
71
71
Laceration(s)
43
43
Abrasion
38
38
Skin Tears
16
16
No Code Available
2
2
Unspecified Tissue Injury
2
2
Tissue Damage
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Zimmer Surgical Inc
II
Feb-13-2024
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