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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
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 508 508
2024 81 81

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 801 801
Break 685 685
Fracture 340 340
Device-Device Incompatibility 149 149
Device Slipped 106 106
Material Deformation 97 97
Material Twisted/Bent 93 93
Migration 93 93
Insufficient Information 43 43
No Apparent Adverse Event 39 39
Crack 35 35
Entrapment of Device 33 33
Difficult to Advance 32 32
Osseointegration Problem 30 30
Device Appears to Trigger Rejection 29 29
Loosening of Implant Not Related to Bone-Ingrowth 27 27
Manufacturing, Packaging or Shipping Problem 26 26
Patient Device Interaction Problem 23 23
Migration or Expulsion of Device 23 23
Patient-Device Incompatibility 21 21
Device Dislodged or Dislocated 20 20
Failure to Cut 17 17
Defective Device 17 17
Material Integrity Problem 16 16
Unintended Movement 15 15
Inadequacy of Device Shape and/or Size 15 15
Material Fragmentation 15 15
Detachment of Device or Device Component 12 12
Packaging Problem 11 11
Difficult to Insert 11 11
Device Damaged Prior to Use 10 10
Noise, Audible 10 10
Use of Device Problem 8 8
Malposition of Device 8 8
Loss of Osseointegration 7 7
Appropriate Term/Code Not Available 7 7
Device Markings/Labelling Problem 6 6
Dull, Blunt 6 6
Nonstandard Device 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
Device Contaminated During Manufacture or Shipping 3 3
Mechanical Jam 3 3
Biocompatibility 3 3
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
Physical Resistance/Sticking 2 2
Incomplete or Inadequate Connection 2 2
Inaccurate Information 1 1
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
Material Protrusion/Extrusion 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Expulsion 1 1
Compatibility Problem 1 1
Device Difficult to Maintain 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 641 641
Unspecified Infection 385 385
No Consequences Or Impact To Patient 343 343
No Code Available 341 341
Pain 147 147
Failure of Implant 146 146
Impaired Healing 133 133
Insufficient Information 129 129
Non-union Bone Fracture 123 123
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 55 55
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
Bacterial Infection 24 24
Inflammation 24 24
Nerve Damage 21 21
Confusion/ Disorientation 21 21
Post Operative Wound Infection 21 21
Difficulty Chewing 19 19
Physical Asymmetry 18 18
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
Ossification 9 9
Foreign Body Reaction 8 8
Necrosis 8 8
Osteolysis 8 8
Fluid Discharge 8 8
Numbness 7 7
Inadequate Osseointegration 7 7
Scar Tissue 7 7
Hematoma 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
Malunion of Bone 3 3
Unspecified Musculoskeletal problem 3 3
Sleep Dysfunction 3 3
Deformity/ Disfigurement 3 3
Cancer 3 3
Arthritis 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
Dizziness 2 2
Perforation 2 2
Skin Erosion 2 2
Hemorrhage/Bleeding 2 2
Hearing Loss 2 2
Fatigue 2 2
Emotional Changes 2 2
Hydrocephalus 2 2
Joint Laxity 2 2
Skin Tears 2 2
Ambulation Difficulties 1 1
Osteopenia/ Osteoporosis 1 1
Joint Dislocation 1 1
Loss of consciousness 1 1
Obstruction/Occlusion 1 1
Decreased Sensitivity 1 1
Convulsion/Seizure 1 1
Movement Disorder 1 1
Bruxism 1 1
Suicidal Ideation 1 1
Cough 1 1
Skin Infection 1 1
Osteomyelitis 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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