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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device driver, prosthesis
Product CodeHWR
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 191 191
2016 436 436
2017 707 707
2018 574 574
2019 678 678
2020 738 738
2021 898 898
2022 980 980
2023 1281 1281
2024 314 314

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3513 3513
Material Twisted/Bent 1297 1297
Material Deformation 635 635
Device-Device Incompatibility 623 623
Naturally Worn 357 357
Crack 267 267
Fracture 183 183
Appropriate Term/Code Not Available 107 107
Entrapment of Device 95 95
Device Slipped 85 85
Mechanical Jam 80 80
Mechanical Problem 70 70
Material Integrity Problem 69 69
Component Missing 49 49
Contamination /Decontamination Problem 40 40
Scratched Material 34 34
Physical Resistance/Sticking 28 28
Adverse Event Without Identified Device or Use Problem 27 27
Connection Problem 23 23
Unintended Movement 22 22
Detachment of Device or Device Component 18 18
Bent 17 17
Material Split, Cut or Torn 17 17
Material Fragmentation 12 12
Difficult to Remove 12 12
Calibration Problem 12 12
Structural Problem 12 12
Insufficient Information 12 12
Use of Device Problem 11 11
Corroded 10 10
No Apparent Adverse Event 10 10
Torn Material 9 9
Difficult to Insert 7 7
Loose or Intermittent Connection 7 7
Detachment Of Device Component 6 6
Material Torqued 5 5
Failure to Cut 5 5
Device Contamination with Chemical or Other Material 5 5
Separation Failure 4 4
Device Operates Differently Than Expected 4 4
Defective Device 4 4
Device Issue 4 4
Improper or Incorrect Procedure or Method 4 4
Disassembly 3 3
Material Discolored 3 3
Dull, Blunt 3 3
Defective Component 3 3
Failure to Disconnect 3 3
Output Problem 3 3
Separation Problem 3 3
Illegible Information 3 3
Device Handling Problem 2 2
Material Distortion 2 2
Flaked 2 2
Fitting Problem 2 2
Sticking 2 2
Misconnection 2 2
Delivered as Unsterile Product 1 1
Output above Specifications 1 1
Peeled/Delaminated 1 1
Off-Label Use 1 1
Material Separation 1 1
Migration or Expulsion of Device 1 1
Device Inoperable 1 1
Incomplete or Missing Packaging 1 1
Residue After Decontamination 1 1
Device Damaged Prior to Use 1 1
Disconnection 1 1
Component Incompatible 1 1
Thermal Decomposition of Device 1 1
Device Reprocessing Problem 1 1
Packaging Problem 1 1
Moisture or Humidity Problem 1 1
Device Difficult to Maintain 1 1
Failure to Align 1 1
Compatibility Problem 1 1
Migration 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3384 3384
No Consequences Or Impact To Patient 1732 1732
No Known Impact Or Consequence To Patient 753 753
No Information 501 501
Insufficient Information 206 206
Not Applicable 125 125
No Code Available 103 103
Foreign Body In Patient 70 70
Device Embedded In Tissue or Plaque 42 42
No Patient Involvement 41 41
Injury 17 17
Spinal Column Injury 4 4
Bone Fracture(s) 4 4
Limb Fracture 4 4
Local Reaction 3 3
Blood Loss 2 2
Hip Fracture 2 2
Failure of Implant 2 2
Foreign Body Reaction 2 2
Pain 2 2
Burn(s) 1 1
Death 1 1
Nerve Damage 1 1
Neuropathy 1 1
Internal Organ Perforation 1 1
Reaction 1 1
Spinal Cord Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet Microfixation, Inc. II Apr-11-2010
2 Biomet U.K., Ltd. II Feb-22-2017
3 Smith & Nephew, Inc., Endoscopy Div. II Jan-29-2016
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