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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 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 2
METICULY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROWARE PRECISION CO., LTD.
  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 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
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 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 1151 1151
Break 985 985
Fracture 518 518
Device-Device Incompatibility 158 158
Material Deformation 142 142
Device Slipped 122 122
Insufficient Information 103 103
Migration 97 97
Material Twisted/Bent 97 97
Migration or Expulsion of Device 55 55
Loosening of Implant Not Related to Bone-Ingrowth 49 49
No Apparent Adverse Event 43 43
Material Fragmentation 42 42
Difficult to Insert 37 37
Crack 36 36
Inadequacy of Device Shape and/or Size 36 36
Osseointegration Problem 36 36
Patient-Device Incompatibility 35 35
Difficult to Advance 34 34
Entrapment of Device 33 33
Device Appears to Trigger Rejection 31 31
Device Dislodged or Dislocated 30 30
Manufacturing, Packaging or Shipping Problem 29 29
Patient Device Interaction Problem 26 26
Unintended Movement 26 26
Defective Device 21 21
Detachment Of Device Component 19 19
Material Integrity Problem 19 19
Failure to Cut 18 18
Detachment of Device or Device Component 18 18
Malposition of Device 17 17
Appropriate Term/Code Not Available 16 16
Material Protrusion/Extrusion 15 15
Device Operates Differently Than Expected 15 15
Noise, Audible 13 13
Device Markings/Labelling Problem 13 13
Device Inoperable 13 13
Use of Device Problem 12 12
Device Damaged Prior to Use 12 12
Loose or Intermittent Connection 12 12
Packaging Problem 12 12
Dull, Blunt 10 10
Loss of Osseointegration 10 10
Biocompatibility 9 9
Failure to Advance 7 7
Nonstandard Device 7 7
Naturally Worn 7 7
Positioning Problem 7 7
Fitting Problem 6 6
Component Missing 5 5
Failure to Osseointegrate 5 5
Improper or Incorrect Procedure or Method 5 5
Expulsion 5 5
Contamination 5 5
Output Problem 5 5
Mechanical Jam 4 4
Material Frayed 4 4
Failure To Adhere Or Bond 4 4
Tear, Rip or Hole in Device Packaging 4 4
Device Contamination with Body Fluid 3 3
Connection Problem 3 3
Bent 3 3
Component Falling 3 3
Material Discolored 3 3
Positioning Failure 3 3
Product Quality Problem 3 3
Material Separation 3 3
Device Contaminated During Manufacture or Shipping 3 3
Physical Resistance/Sticking 3 3
Premature Separation 3 3
Incomplete or Inadequate Connection 2 2
Material Split, Cut or Torn 2 2
Device Operational Issue 2 2
Physical Property Issue 2 2
Difficult to Remove 2 2
Difficult To Position 2 2
Off-Label Use 2 2
Mechanical Problem 2 2
Difficult or Delayed Positioning 2 2
Biofilm coating in Device 2 2
Activation, Positioning or Separation Problem 2 2
Device Issue 2 2
Sticking 2 2
Unstable 1 1
Microbial Contamination of Device 1 1
Malfunction 1 1
Structural Problem 1 1
Failure to Align 1 1
Extrusion 1 1
Human-Device Interface Problem 1 1
Compatibility Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Dent in Material 1 1
Separation Failure 1 1
Loss of or Failure to Bond 1 1
Disassembly 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Occlusion Within Device 1 1
Peeled/Delaminated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 656 656
No Code Available 583 583
Unspecified Infection 553 554
No Consequences Or Impact To Patient 469 469
No Known Impact Or Consequence To Patient 316 316
Pain 217 217
Failure of Implant 213 213
Impaired Healing 199 199
Foreign Body In Patient 162 162
Non-union Bone Fracture 148 148
Insufficient Information 137 137
No Information 134 134
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 71 71
Swelling/ Edema 70 70
No Patient Involvement 67 67
Unspecified Tissue Injury 58 58
Erosion 56 56
Bone Fracture(s) 53 53
Device Embedded In Tissue or Plaque 49 49
Wound Dehiscence 42 42
Hypersensitivity/Allergic reaction 40 40
Swelling 37 37
Reaction 34 34
Limited Mobility Of The Implanted Joint 31 31
Discomfort 29 29
Bacterial Infection 29 29
Purulent Discharge 28 28
Ossification 28 28
Nerve Damage 28 28
Post Operative Wound Infection 27 27
Inflammation 26 26
Headache 26 26
Cerebrospinal Fluid Leakage 24 24
Difficulty Chewing 23 23
Confusion/ Disorientation 21 21
Injury 21 21
Skin Irritation 20 20
Physical Asymmetry 20 20
Difficulty Chewing 19 19
Loss of Range of Motion 18 18
Hematoma 15 15
Skin Inflammation/ Irritation 14 14
Inadequate Pain Relief 13 13
Osteolysis 13 13
Inadequate Osseointegration 12 12
Foreign Body Reaction 12 12
Infiltration into Tissue 12 12
Necrosis 12 12
Scar Tissue 12 12
Not Applicable 11 11
Implant Pain 11 11
Abscess 10 10
Facial Nerve Paralysis 9 9
Visual Impairment 9 9
Numbness 8 8
Fluid Discharge 8 8
Fistula 7 7
Itching Sensation 5 5
Hemorrhage/Bleeding 5 5
Patient Problem/Medical Problem 5 5
Joint Dislocation 5 5
Visual Disturbances 5 5
Tinnitus 4 4
Cancer 4 4
Local Reaction 4 4
Erythema 4 4
Bruise/Contusion 4 4
Eye Pain 4 4
Malunion of Bone 3 3
Unspecified Musculoskeletal problem 3 3
Arthritis 3 3
Granuloma 3 3
Fatigue 3 3
Feeding Problem 3 3
Staphylococcus Aureus 3 3
Hearing Loss 3 3
Neurological Deficit/Dysfunction 3 3
Hydrocephalus 3 3
Sleep Dysfunction 3 3
Vomiting 3 3
Stenosis 3 3
Hypoesthesia 3 3
Deformity/ Disfigurement 3 3
Urticaria 2 2
Rupture 2 2
Dizziness 2 2
Tissue Damage 2 2
Skin Tears 2 2
Blood Loss 2 2
Sweating 2 2
Cognitive Changes 2 2
Tissue Breakdown 2 2
Joint Laxity 2 2
Muscle Spasm(s) 2 2
Perforation 2 2
Seizures 2 2
Skin Erosion 2 2
Skull Fracture 2 2
Debris, Bone Shedding 2 2
Eye Injury 2 2

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
6 Zimmer Biomet, Inc. II May-07-2018
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