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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device plate, bone
Regulation Description Bone plate.
Product CodeJEY
Regulation Number 872.4760
Device Class 2


Premarket Reviews
ManufacturerDecision
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 2
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
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
REOSS GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 7
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
2016 557 557
2017 568 568
2018 607 607
2019 595 595
2020 679 679
2021 180 180

Device Problems MDRs with this Device Problem Events in those MDRs
Break 918 918
Adverse Event Without Identified Device or Use Problem 889 889
Fracture 390 390
Material Deformation 130 130
Insufficient Information 124 124
Device Slipped 96 96
Device-Device Incompatibility 89 89
Unintended Movement 71 71
Migration or Expulsion of Device 65 65
Material Twisted/Bent 55 55
Material Fragmentation 52 52
No Apparent Adverse Event 38 38
Detachment Of Device Component 35 35
Difficult to Insert 35 35
Inadequacy of Device Shape and/or Size 35 35
Crack 32 32
Patient-Device Incompatibility 28 28
Device Appears to Trigger Rejection 28 28
Osseointegration Problem 25 25
Device Dislodged or Dislocated 24 24
Appropriate Term/Code Not Available 24 24
Device Inoperable 23 23
Loose or Intermittent Connection 23 23
Migration 21 21
Malposition of Device 17 17
Manufacturing, Packaging or Shipping Problem 16 16
Device Operates Differently Than Expected 16 16
Material Protrusion/Extrusion 16 16
Difficult to Advance 15 15
Detachment of Device or Device Component 14 14
Loosening of Implant Not Related to Bone-Ingrowth 13 13
Failure to Cut 13 13
Dull, Blunt 13 13
Fitting Problem 12 12
Noise, Audible 12 12
Patient Device Interaction Problem 12 12
Defective Device 11 11
Device Markings/Labelling Problem 10 10
Difficult To Position 9 9
Failure to Advance 7 7
Biocompatibility 7 7
Loss of Osseointegration 6 6
Material Integrity Problem 6 6
Use of Device Problem 6 6
Difficult to Remove 5 5
Naturally Worn 5 5
Contamination 5 5
Entrapment of Device 5 5
Component Falling 4 4
Failure To Adhere Or Bond 4 4
Improper or Incorrect Procedure or Method 4 4
Extrusion 4 4
Mechanical Jam 4 4
Bent 4 4
Device Expiration Issue 4 4
Expulsion 4 4
Failure to Osseointegrate 3 3
Component Missing 3 3
Device Issue 3 3
Device Contamination with Body Fluid 3 3
Sticking 3 3
Premature Separation 3 3
Positioning Problem 3 3
Physical Resistance/Sticking 2 2
Biofilm coating in Device 2 2
Material Discolored 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Damaged Prior to Use 2 2
Biological Environmental Factor 2 2
Connection Problem 2 2
Human Factors Issue 2 2
Material Separation 2 2
Labelling, Instructions for Use or Training Problem 2 2
Mechanical Problem 2 2
Packaging Problem 2 2
Physical Property Issue 2 2
Device Operational Issue 2 2
Device Handling Problem 2 2
Material Split, Cut or Torn 1 1
Device Damaged by Another Device 1 1
Positioning Failure 1 1
Disassembly 1 1
Loss of or Failure to Bond 1 1
Retraction Problem 1 1
Human-Device Interface Problem 1 1
Component or Accessory Incompatibility 1 1
Structural Problem 1 1
Failure to Align 1 1
Expiration Date Error 1 1
Separation Failure 1 1
Microbial Contamination of Device 1 1
Contamination of Device Ingredient or Reagent 1 1
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Defective Component 1 1
Malfunction 1 1
Difficult or Delayed Positioning 1 1
Unstable 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 692 692
Unspecified Infection 519 520
No Consequences Or Impact To Patient 483 483
No Known Impact Or Consequence To Patient 475 475
Pain 219 219
Impaired Healing 204 204
Failure of Implant 197 197
No Information 149 149
Foreign Body In Patient 119 119
No Clinical Signs, Symptoms or Conditions 115 115
Device Embedded In Tissue or Plaque 108 108
Non-union Bone Fracture 94 94
No Patient Involvement 69 69
Erosion 54 54
Bone Fracture(s) 49 49
Bacterial Infection 39 39
Limited Mobility Of The Implanted Joint 39 39
Reaction 38 38
Swelling 37 37
Wound Dehiscence 32 32
Ossification 28 28
Purulent Discharge 28 28
Hypersensitivity/Allergic reaction 27 27
Headache 25 25
Difficulty Chewing 23 23
Discomfort 22 22
Nerve Damage 22 22
Injury 21 21
Swelling/ Edema 20 20
Skin Irritation 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Post Operative Wound Infection 19 19
Cerebrospinal Fluid Leakage 18 18
Hematoma 15 15
Inadequate Pain Relief 13 13
Necrosis 13 13
Facial Nerve Paralysis 13 13
Infiltration into Tissue 12 12
Visual Impairment 11 11
Not Applicable 11 11
Insufficient Information 10 10
Numbness 10 10
Abscess 9 9
Sedation 8 8
Foreign Body Reaction 8 8
Inadequate Osseointegration 7 7
Osteolysis 7 7
Fluid Discharge 7 7
Patient Problem/Medical Problem 6 6
Scar Tissue 6 6
Unspecified Tissue Injury 5 5
Joint Dislocation 5 5
Hearing Loss 5 5
Inflammation 4 4
Erythema 4 4
Cancer 4 4
Fistula 4 4
Itching Sensation 4 4
Bruise/Contusion 4 4
Nausea 3 3
Vomiting 3 3
Tissue Damage 3 3
Hydrocephalus 3 3
Hypoesthesia 3 3
Sleep Dysfunction 3 3
Feeding Problem 3 3
Neurological Deficit/Dysfunction 3 3
Loss of Range of Motion 3 3
Staphylococcus Aureus 3 3
Muscle Spasm(s) 2 2
Fall 2 2
Host-Tissue Reaction 2 2
Cognitive Changes 2 2
Rupture 2 2
Sweating 2 2
Tissue Breakdown 2 2
Blood Loss 2 2
Skull Fracture 2 2
Urticaria 2 2
Seizures 2 2
Eye Injury 2 2
Debris, Bone Shedding 2 2
Hemorrhage/Bleeding 2 2
Granuloma 2 2
Hyperglycemia 1 1
Laceration(s) 1 1
Infarction, Cerebral 1 1
Death 1 1
Bradycardia 1 1
Seroma 1 1
Pneumonia 1 1
Pneumothorax 1 1
Blurred Vision 1 1
Weakness 1 1
Tingling 1 1
Dysphasia 1 1
Therapeutic Response, Decreased 1 1
Alteration In Body Temperature 1 1
Fibrosis 1 1
Bruxism 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 (USA) Products LLC II Jun-07-2016
4 Synthes Produktions GmbH II Jul-30-2020
5 Synthes, Inc. II Jul-24-2020
6 Zimmer Biomet, Inc. II May-07-2018
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