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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dispenser, cement
Product CodeKIH
Regulation Number 888.4200
Device Class 1

MDR Year MDR Reports MDR Events
2014 12 12
2015 6 6
2016 5 5
2017 14 14
2018 15 15
2019 29 29
2020 23 23
2021 30 30
2022 26 26
2023 30 30
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 66 66
Mechanical Jam 23 23
Adverse Event Without Identified Device or Use Problem 21 21
Leak/Splash 18 18
Appropriate Term/Code Not Available 12 12
Failure to Eject 11 11
Chemical Problem 9 9
Mechanics Altered 7 7
Device-Device Incompatibility 6 6
Defective Device 5 5
Fracture 4 4
Loss of or Failure to Bond 4 4
Defective Component 4 4
Entrapment of Device 3 3
Migration or Expulsion of Device 3 3
Device Operates Differently Than Expected 3 3
Device Packaging Compromised 2 2
Malposition of Device 2 2
Connection Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Deformation 2 2
Partial Blockage 2 2
Difficult to Remove 2 2
Device Handling Problem 2 2
Noise, Audible 1 1
Explosion 1 1
Output Problem 1 1
Packaging Problem 1 1
Pumping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Separation 1 1
Device Slipped 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Fluid/Blood Leak 1 1
Failure to Advance 1 1
Expiration Date Error 1 1
Detachment Of Device Component 1 1
No Display/Image 1 1
Failure to Prime 1 1
Off-Label Use 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Extrusion 1 1
Inaccurate Dispensing 1 1
Detachment of Device or Device Component 1 1
Device Operational Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 64 64
No Consequences Or Impact To Patient 44 44
No Known Impact Or Consequence To Patient 23 23
Foreign Body In Patient 10 10
Insufficient Information 10 10
No Code Available 9 9
Pain 9 9
Extravasation 8 8
Device Embedded In Tissue or Plaque 8 8
Bone Fracture(s) 3 3
Abrasion 2 2
Necrosis 2 2
Nerve Damage 2 2
Non-union Bone Fracture 2 2
No Information 2 2
Numbness 2 2
Spinal Cord Injury 2 2
No Patient Involvement 2 2
Vertebral Fracture 1 1
Joint Laxity 1 1
Post Operative Wound Infection 1 1
Paraplegia 1 1
Sudden Cardiac Death 1 1
Weight Changes 1 1
Nervous System Injury 1 1
Reaction 1 1
Sedation 1 1
Neuropathy 1 1
Synovitis 1 1
Adhesion(s) 1 1
Death 1 1
Dysphagia/ Odynophagia 1 1
Edema 1 1
Hair Loss 1 1
Failure of Implant 1 1
Inflammation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BIOMET FRANCE S.A.R.L. II Jun-10-2015
2 Orthovita, Inc. II Sep-12-2011
3 Orthovita, Inc., dBA Stryker Orthobiologics. II Sep-16-2015
4 Stryker Instruments Div. of Stryker Corporation II Mar-12-2012
5 Zimmer Biomet, Inc. II Apr-01-2019
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