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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device expander, surgical, skin graft
Product CodeFZW
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 468 468
2020 486 486
2021 554 554
2022 510 510
2023 606 606
2024 290 290

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1500 1500
Material Twisted/Bent 701 701
Physical Resistance/Sticking 395 395
Appropriate Term/Code Not Available 169 169
Material Deformation 90 90
Naturally Worn 76 76
Mechanical Jam 70 70
Mechanical Problem 60 60
Break 46 46
Patient Device Interaction Problem 39 39
Difficult to Remove 34 34
Fitting Problem 33 33
Calibration Problem 32 32
Insufficient Information 28 28
Component Missing 28 28
Dull, Blunt 26 26
Material Integrity Problem 26 26
Delivered as Unsterile Product 15 15
Output Problem 13 13
Activation, Positioning or Separation Problem 12 12
Positioning Problem 11 11
Loose or Intermittent Connection 9 9
Device Damaged Prior to Use 9 9
Difficult to Advance 9 9
No Apparent Adverse Event 9 9
Activation Failure 8 8
Material Split, Cut or Torn 7 7
Activation Problem 7 7
Detachment of Device or Device Component 7 7
Material Too Rigid or Stiff 7 7
Connection Problem 6 6
Material Discolored 6 6
Difficult to Open or Close 5 5
Misassembled 5 5
Dent in Material 5 5
Failure to Align 5 5
Degraded 5 5
Defective Device 5 5
Defective Component 5 5
Device Markings/Labelling Problem 5 5
Device Slipped 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Packaging Problem 4 4
Electrical /Electronic Property Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Failure to Advance 3 3
Failure to Disconnect 3 3
Gas/Air Leak 2 2
Structural Problem 2 2
Contamination /Decontamination Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1873 1873
No Patient Involvement 515 515
No Consequences Or Impact To Patient 311 311
No Known Impact Or Consequence To Patient 191 191
Abrasion 57 57
Insufficient Information 34 34
Laceration(s) 30 30
No Code Available 16 16
Injury 4 4
Unspecified Tissue Injury 2 2
No Information 1 1
Oversedation 1 1
Tissue Damage 1 1
Skin Tears 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Surgical Inc II Feb-13-2024
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