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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device plate, bone
Product CodeJEY
Regulation Number 872.4760
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 1
  1.  K202969  Biomet Microfixation OmniMax MMF System
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 L.P.
  SUBSTANTIALLY EQUIVALENT 2
MCI MEDICAL CONCEPT INNOVATION INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDCAD
  SUBSTANTIALLY EQUIVALENT 2
METICULY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MONTJADE ENGINEERING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
REOSS GMBH
  SUBSTANTIALLY EQUIVALENT 1
SITES MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CRANIOMAXILLOFACIAL
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CRANIOMAXILLOFACIAL (CMF)
  SUBSTANTIALLY EQUIVALENT 1
STRYKER LEIBINGER GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
STRYKER LEIBINGER MICRO IMPLANTS
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 595 595
2020 680 680
2021 451 451
2022 344 344
2023 509 509
2024 141 141

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 825 825
Break 685 685
Fracture 344 344
Device-Device Incompatibility 151 151
Device Slipped 106 106
Material Deformation 97 97
Material Twisted/Bent 93 93
Migration 93 93
Loosening of Implant Not Related to Bone-Ingrowth 46 46
Insufficient Information 43 43
No Apparent Adverse Event 41 41
Crack 35 35
Entrapment of Device 33 33
Difficult to Advance 32 32
Device Appears to Trigger Rejection 31 31
Osseointegration Problem 30 30
Migration or Expulsion of Device 27 27
Manufacturing, Packaging or Shipping Problem 26 26
Patient Device Interaction Problem 23 23
Patient-Device Incompatibility 21 21
Device Dislodged or Dislocated 20 20
Defective Device 19 19
Failure to Cut 17 17
Material Integrity Problem 16 16
Unintended Movement 15 15
Inadequacy of Device Shape and/or Size 15 15
Material Fragmentation 15 15
Device Damaged Prior to Use 12 12
Detachment of Device or Device Component 12 12
Packaging Problem 11 11
Difficult to Insert 11 11
Noise, Audible 10 10
Use of Device Problem 8 8
Malposition of Device 8 8
Loss of Osseointegration 7 7
Nonstandard Device 7 7
Appropriate Term/Code Not Available 7 7
Device Markings/Labelling Problem 6 6
Dull, Blunt 6 6
Component Missing 5 5
Naturally Worn 5 5
Output Problem 5 5
Positioning Problem 4 4
Tear, Rip or Hole in Device Packaging 4 4
Improper or Incorrect Procedure or Method 4 4
Material Frayed 4 4
Failure to Osseointegrate 3 3
Device Contamination with Body Fluid 3 3
Mechanical Jam 3 3
Biocompatibility 3 3
Device Contaminated During Manufacture or Shipping 3 3
Physical Resistance/Sticking 3 3
Incomplete or Inadequate Connection 2 2
Activation, Positioning or Separation Problem 2 2
Material Separation 2 2
Difficult or Delayed Positioning 2 2
Positioning Failure 2 2
Material Discolored 2 2
Off-Label Use 2 2
Product Quality Problem 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 1 1
Misconnection 1 1
Failure to Sense 1 1
Loss of or Failure to Bond 1 1
Fitting Problem 1 1
Microbial Contamination of Device 1 1
Failure to Advance 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Material Protrusion/Extrusion 1 1
Expulsion 1 1
Compatibility Problem 1 1
Device Difficult to Maintain 1 1
Material Split, Cut or Torn 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 655 655
Unspecified Infection 392 392
No Consequences Or Impact To Patient 343 343
No Code Available 341 341
Failure of Implant 165 165
Pain 147 147
Non-union Bone Fracture 141 141
Insufficient Information 137 137
Impaired Healing 133 133
Foreign Body In Patient 115 115
No Known Impact Or Consequence To Patient 96 96
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 71 71
Swelling/ Edema 70 70
Unspecified Tissue Injury 57 57
Erosion 55 55
Bone Fracture(s) 45 45
No Patient Involvement 43 43
No Information 38 38
Wound Dehiscence 31 31
Discomfort 28 28
Hypersensitivity/Allergic reaction 27 27
Purulent Discharge 26 26
Inflammation 25 25
Bacterial Infection 24 24
Nerve Damage 21 21
Confusion/ Disorientation 21 21
Post Operative Wound Infection 21 21
Physical Asymmetry 20 20
Difficulty Chewing 19 19
Swelling 18 18
Injury 17 17
Loss of Range of Motion 17 17
Device Embedded In Tissue or Plaque 17 17
Headache 16 16
Skin Inflammation/ Irritation 14 14
Limited Mobility Of The Implanted Joint 13 13
Inadequate Pain Relief 13 13
Cerebrospinal Fluid Leakage 13 13
Skin Irritation 12 12
Reaction 11 11
Implant Pain 11 11
Difficulty Chewing 10 10
Necrosis 9 9
Ossification 9 9
Foreign Body Reaction 8 8
Hematoma 8 8
Fluid Discharge 8 8
Osteolysis 8 8
Inadequate Osseointegration 7 7
Numbness 7 7
Scar Tissue 7 7
Facial Nerve Paralysis 6 6
Abscess 5 5
Fistula 5 5
Visual Disturbances 5 5
Tinnitus 4 4
Local Reaction 4 4
Erythema 4 4
Itching Sensation 4 4
Bruise/Contusion 4 4
Eye Pain 4 4
Cancer 3 3
Deformity/ Disfigurement 3 3
Sleep Dysfunction 3 3
Unspecified Musculoskeletal problem 3 3
Malunion of Bone 3 3
Arthritis 3 3
Hemorrhage/Bleeding 3 3
Feeding Problem 3 3
Granuloma 3 3
Neurological Deficit/Dysfunction 3 3
Visual Impairment 3 3
Hypoesthesia 3 3
Stenosis 3 3
Urticaria 2 2
Rupture 2 2
Perforation 2 2
Skin Erosion 2 2
Hearing Loss 2 2
Fatigue 2 2
Emotional Changes 2 2
Joint Laxity 2 2
Skin Tears 2 2
Dizziness 2 2
Hydrocephalus 2 2
Convulsion/Seizure 1 1
Movement Disorder 1 1
Bruxism 1 1
Suicidal Ideation 1 1
Cough 1 1
Decreased Sensitivity 1 1
Joint Dislocation 1 1
Loss of consciousness 1 1
Obstruction/Occlusion 1 1
Ambulation Difficulties 1 1
Osteopenia/ Osteoporosis 1 1
Osteomyelitis 1 1
Skin Infection 1 1
Increased Appetite 1 1
Congenital Defect/Deformity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Materialise N.V. II Aug-03-2023
3 Materialise N.V. II Apr-06-2020
4 Synthes Produktions GmbH II Jul-30-2020
5 Synthes, Inc. II Jul-24-2020
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