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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device impactor
Product CodeHWA
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 1550 1550
2020 1477 1477
2021 2006 2006
2022 2086 2086
2023 2245 2245
2024 495 495

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7109 7109
Crack 969 969
Naturally Worn 776 776
Device-Device Incompatibility 604 604
Fracture 538 538
Material Twisted/Bent 332 332
Scratched Material 175 175
Material Deformation 172 172
Contamination /Decontamination Problem 163 163
Material Integrity Problem 118 118
No Apparent Adverse Event 74 74
Mechanical Jam 71 71
Adverse Event Without Identified Device or Use Problem 67 67
Detachment of Device or Device Component 52 52
Unintended Movement 52 52
Entrapment of Device 34 34
Component Missing 31 31
Illegible Information 30 30
Physical Resistance/Sticking 23 23
Failure to Disconnect 19 19
Material Discolored 19 19
Mechanical Problem 17 17
Loose or Intermittent Connection 16 16
Device Slipped 12 12
Material Fragmentation 12 12
Appropriate Term/Code Not Available 12 12
Device Contamination with Chemical or Other Material 11 11
Difficult to Remove 10 10
Use of Device Problem 8 8
Structural Problem 8 8
Manufacturing, Packaging or Shipping Problem 7 7
Corroded 7 7
Off-Label Use 6 6
Compatibility Problem 6 6
Connection Problem 6 6
Insufficient Information 6 6
Defective Device 5 5
Deformation Due to Compressive Stress 5 5
Improper or Incorrect Procedure or Method 4 4
Fitting Problem 4 4
Device Dislodged or Dislocated 4 4
Positioning Problem 3 3
Dull, Blunt 3 3
Failure to Cut 2 2
Device Damaged Prior to Use 2 2
Problem with Sterilization 2 2
Flaked 2 2
Material Disintegration 2 2
Degraded 2 2
Separation Problem 2 2
Failure to Clean Adequately 2 2
Device Damaged by Another Device 2 2
Osseointegration Problem 2 2
Mechanics Altered 1 1
Activation, Positioning or Separation Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Missing Information 1 1
Difficult or Delayed Separation 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Handling Problem 1 1
Missing Test Results 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1
Accessory Incompatible 1 1
Device Reprocessing Problem 1 1
Difficult to Insert 1 1
Product Quality Problem 1 1
Device Difficult to Setup or Prepare 1 1
Unstable 1 1
Material Separation 1 1
Defective Component 1 1
Solder Joint Fracture 1 1
Residue After Decontamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6650 6650
No Consequences Or Impact To Patient 2552 2552
Insufficient Information 384 384
No Code Available 183 183
No Known Impact Or Consequence To Patient 125 125
No Patient Involvement 64 64
Not Applicable 62 62
Foreign Body In Patient 32 32
No Information 13 13
Device Embedded In Tissue or Plaque 6 6
Unspecified Infection 5 5
Pain 5 5
Injury 4 4
Failure of Implant 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Bone Fracture(s) 2 2
Hematoma 1 1
Thrombosis 1 1
Non-union Bone Fracture 1 1
Reaction 1 1
Needle Stick/Puncture 1 1
Patient Problem/Medical Problem 1 1
Inadequate Osseointegration 1 1
Osteopenia/ Osteoporosis 1 1
Unspecified Musculoskeletal problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Enztec Limited II Jan-24-2020
2 Exactech, Inc. II Jun-30-2023
3 Exactech, Inc. II Sep-10-2019
4 XTANT Medical II Jul-04-2020
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