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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device plate, bone
Product CodeJEY
Regulation Number 872.4760
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 1
DELPHOS IMPLANTS - IND.COM. IMPORTACAO E EXPORTACAO DE
  SUBSTANTIALLY EQUIVALENT 1
FAICO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
INDUSTRIAS MEDICAS SAMPEDRO S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN LP
  SUBSTANTIALLY EQUIVALENT 2
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 3
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 2
MATRIX SURGICAL HOLDINGS, LLC/MATRIX SURGICAL USA
  SUBSTANTIALLY EQUIVALENT 1
MCI MEDICAL CONCEPT INNOVATION INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDCAD
  SUBSTANTIALLY EQUIVALENT 1
MONTJADE ENGINEERING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD..
  SUBSTANTIALLY EQUIVALENT 1
REOSS GMBH
  SUBSTANTIALLY EQUIVALENT 1
SITES MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 7
STRYKER LEIBINGER MICRO IMPLANTS
  SUBSTANTIALLY EQUIVALENT 1
SURGIDENT
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VISIONARE LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 568 568
2018 607 607
2019 595 595
2020 679 679
2021 451 451
2022 187 187

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 901 901
Break 849 849
Fracture 390 390
Material Deformation 132 132
Device-Device Incompatibility 123 123
Device Slipped 106 106
Insufficient Information 96 96
Material Twisted/Bent 70 70
Migration or Expulsion of Device 45 45
Material Fragmentation 42 42
No Apparent Adverse Event 37 37
Difficult to Insert 36 36
Crack 34 34
Migration 34 34
Patient-Device Incompatibility 32 32
Inadequacy of Device Shape and/or Size 30 30
Device Appears to Trigger Rejection 28 28
Osseointegration Problem 28 28
Unintended Movement 26 26
Device Dislodged or Dislocated 22 22
Difficult to Advance 19 19
Detachment Of Device Component 19 19
Appropriate Term/Code Not Available 16 16
Manufacturing, Packaging or Shipping Problem 16 16
Material Protrusion/Extrusion 15 15
Loosening of Implant Not Related to Bone-Ingrowth 15 15
Device Operates Differently Than Expected 15 15
Failure to Cut 15 15
Defective Device 14 14
Detachment of Device or Device Component 14 14
Entrapment of Device 13 13
Device Inoperable 13 13
Patient Device Interaction Problem 13 13
Loose or Intermittent Connection 12 12
Malposition of Device 12 12
Noise, Audible 11 11
Dull, Blunt 10 10
Biocompatibility 9 9
Device Markings/Labelling Problem 9 9
Packaging Problem 9 9
Material Integrity Problem 7 7
Failure to Advance 7 7
Fitting Problem 6 6
Loss of Osseointegration 6 6
Use of Device Problem 6 6
Contamination 5 5
Naturally Worn 5 5
Output Problem 5 5
Positioning Problem 5 5
Mechanical Jam 4 4
Failure To Adhere Or Bond 4 4
Failure to Osseointegrate 4 4
Expulsion 4 4
Device Contaminated During Manufacture or Shipping 3 3
Component Missing 3 3
Device Contamination with Body Fluid 3 3
Bent 3 3
Component Falling 3 3
Premature Separation 3 3
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 2 2
Incomplete or Inadequate Connection 2 2
Physical Property Issue 2 2
Material Discolored 2 2
Mechanical Problem 2 2
Biofilm coating in Device 2 2
Improper or Incorrect Procedure or Method 2 2
Material Separation 2 2
Sticking 2 2
Difficult to Remove 2 2
Difficult To Position 2 2
Device Issue 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Damaged Prior to Use 2 2
Connection Problem 2 2
Device Operational Issue 2 2
Device Damaged by Another Device 1 1
Material Distortion 1 1
Extrusion 1 1
Human-Device Interface Problem 1 1
Compatibility Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Microbial Contamination of Device 1 1
Dent in Material 1 1
Separation Failure 1 1
Malfunction 1 1
Structural Problem 1 1
Failure to Align 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Misconnection 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Occlusion Within Device 1 1
Peeled/Delaminated 1 1
Unstable 1 1
Loss of or Failure to Bond 1 1
Difficult or Delayed Positioning 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 583 583
Unspecified Infection 497 498
No Consequences Or Impact To Patient 469 469
No Clinical Signs, Symptoms or Conditions 367 367
No Known Impact Or Consequence To Patient 316 316
Pain 188 188
Impaired Healing 180 180
Failure of Implant 144 144
No Information 134 134
Foreign Body In Patient 121 121
No Patient Involvement 67 67
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 61 61
Non-union Bone Fracture 55 55
Erosion 54 54
Bone Fracture(s) 49 49
Device Embedded In Tissue or Plaque 49 49
Swelling 37 37
Wound Dehiscence 34 34
Reaction 34 34
Swelling/ Edema 32 32
Limited Mobility Of The Implanted Joint 31 31
Insufficient Information 30 30
Bacterial Infection 29 29
Purulent Discharge 28 28
Hypersensitivity/Allergic reaction 25 25
Cerebrospinal Fluid Leakage 24 24
Ossification 24 24
Post Operative Wound Infection 24 24
Difficulty Chewing 23 23
Nerve Damage 22 22
Injury 21 21
Skin Irritation 20 20
Headache 20 20
Discomfort 17 17
Hematoma 14 14
Inadequate Pain Relief 13 13
Unspecified Tissue Injury 12 12
Infiltration into Tissue 12 12
Not Applicable 11 11
Necrosis 10 10
Foreign Body Reaction 10 10
Facial Nerve Paralysis 9 9
Abscess 9 9
Visual Impairment 9 9
Fluid Discharge 8 8
Inadequate Osseointegration 7 7
Implant Pain 7 7
Physical Asymmetry 6 6
Numbness 6 6
Scar Tissue 6 6
Loss of Range of Motion 5 5
Visual Disturbances 5 5
Inflammation 5 5
Osteolysis 5 5
Difficulty Chewing 5 5
Patient Problem/Medical Problem 5 5
Cancer 4 4
Joint Dislocation 4 4
Itching Sensation 4 4
Bruise/Contusion 4 4
Erythema 4 4
Fistula 3 3
Feeding Problem 3 3
Hemorrhage/Bleeding 3 3
Hearing Loss 3 3
Neurological Deficit/Dysfunction 3 3
Vomiting 3 3
Hypoesthesia 3 3
Staphylococcus Aureus 3 3
Sleep Dysfunction 3 3
Hydrocephalus 3 3
Skin Inflammation/ Irritation 2 2
Cognitive Changes 2 2
Blood Loss 2 2
Sweating 2 2
Tissue Breakdown 2 2
Dizziness 2 2
Rupture 2 2
Urticaria 2 2
Tissue Damage 2 2
Local Reaction 2 2
Skull Fracture 2 2
Seizures 2 2
Muscle Spasm(s) 2 2
Granuloma 2 2
Eye Injury 2 2
Fatigue 2 2
Emotional Changes 2 2
Debris, Bone Shedding 2 2
Host-Tissue Reaction 2 2
Arthritis 2 2
Autoimmune Reaction 1 1
Bradycardia 1 1
Anemia 1 1
Burn(s) 1 1
Infarction, Cerebral 1 1
Cyst(s) 1 1
Fever 1 1
Hearing Impairment 1 1
Hemorrhage, Cerebral 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Materialise N.V. II Apr-06-2020
3 Synthes Produktions GmbH II Jul-30-2020
4 Synthes, Inc. II Jul-24-2020
5 Zimmer Biomet, Inc. II May-07-2018
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