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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bone cement
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Product CodeLOD
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
BIOMET INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
KULZER, LLC
  SUBSTANTIALLY EQUIVALENT 5
SYNTHES (USA) PRODUCTS LLC / MEDICAL DEVICE BUSINESS SERVICE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Loss of or Failure to Bond 2665
Adverse Event Without Identified Device or Use Problem 442
Insufficient Information 372
Loose or Intermittent Connection 250
Loss of Osseointegration 211
Loosening of Implant Not Related to Bone-Ingrowth 176
Appropriate Term/Code Not Available 165
Unsealed Device Packaging 115
Migration or Expulsion of Device 111
Failure To Adhere Or Bond 92
Break 77
Packaging Problem 70
Device Operates Differently Than Expected 65
Device Damaged Prior to Use 40
Improper Chemical Reaction 39
Infusion or Flow Problem 38
Device Difficult to Setup or Prepare 37
Manufacturing, Packaging or Shipping Problem 33
Tear, Rip or Hole in Device Packaging 31
Shipping Damage or Problem 27
Migration 24
Fracture 24
Unstable 23
Chemical Problem 23
Device Packaging Compromised 20
Leak / Splash 19
Use of Device Problem 18
Defective Device 17
Device Emits Odor 16
Osseointegration Problem 14
Delivered as Unsterile Product 13
Device Contaminated during manufacture or shipping 11
Device Contamination with Chemical or Other Material 10
Device Dislodged or Dislocated 9
Device Handling Problem 9
Mechanical Problem 8
Fluid Leak 8
Noise, Audible 8
Difficult to Open or Remove Packaging Material 8
Device Slipped 8
Expiration Date Error 7
Material Deformation 7
Material Integrity Problem 6
Naturally Worn 6
Physical Resistance / Sticking 5
Missing Information 5
Improper or Incorrect Procedure or Method 5
No Apparent Adverse Event 5
Moisture or Humidity Problem 5
Clumping in Device or Device Ingredient 5
Disassembly 5
Unintended Movement 4
Crack 4
Material Discolored 4
Patient-Device Incompatibility 4
Difficult to Insert 4
Inadequate or Insufficient Training 4
Contamination During Use 3
Material Fragmentation 3
Incomplete or Missing Packaging 3
Component Missing 3
Sharp Edges 3
Malposition of device 3
Sticking 3
Failure to Eject 3
Failure To Unwrap 3
Application Program Problem 3
Device Expiration Issue 3
Material Too Rigid or Stiff 3
Product Quality Problem 2
Failure to Advance 2
Compatibility Problem 2
Premature Activation 2
Use of Incorrect Control Settings 2
Device Ingredient or Reagent Problem 2
Positioning Problem 2
Torn Material 2
Detachment Of Device Component 2
Contamination of Device Ingredient or Reagent 2
Activation Problem 2
Fumes or Vapors 2
Device Operational Issue 2
Optical Discoloration 2
Contamination / decontamination Problem 2
Disconnection 2
Off-Label Use 2
Defective Component 2
Failure to Align 1
Difficult or Delayed Activation 1
Device Markings / Labelling Problem 1
Backflow 1
Scratched Material 1
Device Misassembled During Manufacturing / Shipping 1
Positioning Failure 1
Material Perforation 1
Material Split, Cut or Torn 1
Separation Failure 1
Charred 1
Fire 1
Device Difficult to Maintain 1
Total Device Problems 5516

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Nov-06-2017
2 Encore Medical, Lp II Aug-19-2016
3 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
4 Zimmer Biomet, Inc. II Apr-25-2017
5 Zimmer, Inc. II Dec-31-2014

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