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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
ARKIN CONSULTING GROUP
  SUBSTANTIALLY EQUIVALENT 1
BIOMATERIALS KOREA INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 7
DELPHOS IMPLANTS - IND.COM. IMPORTACAO E EXPORTACAO DE
  SUBSTANTIALLY EQUIVALENT 1
FAICO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
FRONTIER DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLADENT, LTD.
  SUBSTANTIALLY EQUIVALENT 1
INDUSTRIAS MEDICAS SAMPEDRO S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
INION OY
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
KLS MARTIN LP
  SUBSTANTIALLY EQUIVALENT 2
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 5
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
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
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEGAGEN IMPLANT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MONTJADE ENGINEERING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEOBIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEOORTHO PRODUTOS ORTOPEDICOS S/A
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD..
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED L.P.
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
POREX SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
REOSS GMBH
  SUBSTANTIALLY EQUIVALENT 1
SITES MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 13
STRYKER CRANIOMAXILLOFACIAL
  SUBSTANTIALLY EQUIVALENT 2
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)
  SUBSTANTIALLY EQUIVALENT 4
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES INC
  SUBSTANTIALLY EQUIVALENT 4
VISIONARE LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 616 616
2015 767 767
2016 556 556
2017 568 568
2018 607 607
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
Break 1641 1641
Adverse Event Without Identified Device or Use Problem 1596 1596
Fracture 654 654
Insufficient Information 238 238
Device-Device Incompatibility 167 167
Material Deformation 151 151
Device Slipped 144 144
Material Twisted/Bent 99 99
Migration 97 97
Material Fragmentation 97 97
Migration or Expulsion of Device 92 92
Unintended Movement 83 83
Device Operates Differently Than Expected 77 77
Loose or Intermittent Connection 66 66
Device Dislodged or Dislocated 65 65
Appropriate Term/Code Not Available 61 61
Detachment Of Device Component 56 56
Inadequacy of Device Shape and/or Size 56 56
Difficult to Insert 55 55
No Apparent Adverse Event 43 43
Difficult to Advance 40 40
Malposition of Device 40 40
Patient-Device Incompatibility 39 39
Crack 39 39
Osseointegration Problem 36 36
Detachment of Device or Device Component 35 35
Entrapment of Device 34 34
Fitting Problem 34 34
Manufacturing, Packaging or Shipping Problem 32 32
Loosening of Implant Not Related to Bone-Ingrowth 30 30
Device Appears to Trigger Rejection 29 29
Patient Device Interaction Problem 26 26
Device Inoperable 24 24
Difficult to Remove 22 22
Sticking 21 21
Defective Device 21 21
Material Integrity Problem 19 19
Failure to Cut 18 18
Dull, Blunt 17 17
Improper or Incorrect Procedure or Method 17 17
Material Protrusion/Extrusion 17 17
Noise, Audible 17 17
Positioning Problem 16 16
Device Markings/Labelling Problem 14 14
Failure To Adhere Or Bond 14 14
Difficult To Position 13 13
Failure to Osseointegrate 13 13
Use of Device Problem 13 13
Packaging Problem 13 13
Device Expiration Issue 12 12
Extrusion 11 11
Bent 10 10
Loss of Osseointegration 10 10
Device Damaged Prior to Use 10 10
Failure to Align 9 9
Metal Shedding Debris 9 9
Biocompatibility 9 9
Failure to Advance 8 8
Component Missing 7 7
Material Separation 7 7
Contamination 7 7
Mechanical Jam 7 7
Naturally Worn 7 7
Device Or Device Fragments Location Unknown 6 6
Nonstandard Device 6 6
Occlusion Within Device 5 5
Peeled/Delaminated 5 5
Connection Problem 5 5
Output Problem 5 5
Expulsion 5 5
Material Frayed 4 4
Mechanical Problem 4 4
Component Falling 4 4
Tear, Rip or Hole in Device Packaging 4 4
Device Contamination with Body Fluid 3 3
Device Issue 3 3
Product Quality Problem 3 3
Device Reprocessing Problem 3 3
Material Discolored 3 3
Difficult or Delayed Positioning 3 3
Positioning Failure 3 3
Device Contaminated During Manufacture or Shipping 3 3
Device Disinfection Or Sterilization Issue 3 3
Torn Material 3 3
Premature Separation 3 3
Physical Property Issue 2 2
Device Handling Problem 2 2
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 2 2
Incomplete or Inadequate Connection 2 2
Activation, Positioning or Separation Problem 2 2
Device Operational Issue 2 2
Device Damaged by Another Device 2 2
Biological Environmental Factor 2 2
Device Contamination with Chemical or Other Material 2 2
Human Factors Issue 2 2
Human-Device Interface Problem 2 2
Biofilm coating in Device 2 2
Labelling, Instructions for Use or Training Problem 2 2
Delivered as Unsterile Product 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 891 892
No Code Available 866 866
No Known Impact Or Consequence To Patient 858 858
No Clinical Signs, Symptoms or Conditions 642 642
No Consequences Or Impact To Patient 542 542
Pain 392 392
Failure of Implant 353 353
Impaired Healing 282 282
Device Embedded In Tissue or Plaque 211 211
Foreign Body In Patient 207 207
Non-union Bone Fracture 196 196
No Information 176 176
Insufficient Information 129 129
No Patient Involvement 87 87
Swelling 73 73
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 71 71
Swelling/ Edema 70 70
Post Operative Wound Infection 70 70
Reaction 67 67
Bone Fracture(s) 65 65
Erosion 58 58
Unspecified Tissue Injury 56 56
Wound Dehiscence 51 51
Infiltration into Tissue 50 50
Hypersensitivity/Allergic reaction 50 50
Discomfort 48 48
Limited Mobility Of The Implanted Joint 48 48
Bacterial Infection 41 41
Headache 37 37
Ossification 35 35
Inflammation 34 34
Nerve Damage 34 34
Rupture 33 33
Sedation 32 32
Foreign Body Reaction 32 32
Cerebrospinal Fluid Leakage 30 30
Purulent Discharge 30 30
Difficulty Chewing 25 25
Injury 24 24
Confusion/ Disorientation 21 21
Fistula 21 21
Skin Irritation 20 20
Loss of Range of Motion 19 19
Difficulty Chewing 19 19
Fluid Discharge 18 18
Physical Asymmetry 18 18
Osteolysis 18 18
Facial Nerve Paralysis 16 16
Hematoma 15 15
Necrosis 15 15
Abscess 14 14
Skin Inflammation/ Irritation 14 14
Inadequate Pain Relief 13 13
Staphylococcus Aureus 13 13
Scar Tissue 12 12
Inadequate Osseointegration 12 12
Numbness 12 12
Visual Impairment 11 11
Implant Pain 11 11
Not Applicable 11 11
Joint Dislocation 10 10
Hemorrhage/Bleeding 8 8
Visual Disturbances 6 6
Patient Problem/Medical Problem 6 6
Cancer 5 5
Tissue Damage 5 5
Complaint, Ill-Defined 5 5
Hearing Loss 5 5
Itching Sensation 5 5
Cellulitis 5 5
Erythema 4 4
Bruise/Contusion 4 4
Muscle Weakness 4 4
Feeding Problem 4 4
Fever 4 4
Tinnitus 4 4
Dizziness 4 4
Discharge 4 4
Seizures 4 4
Local Reaction 4 4
Eye Pain 4 4
Malunion of Bone 3 3
Unspecified Musculoskeletal problem 3 3
Hydrocephalus 3 3
Tissue Breakdown 3 3
Skin Erosion 3 3
Paresis 3 3
Stenosis 3 3
Vomiting 3 3
Deformity/ Disfigurement 3 3
Hypoesthesia 3 3
Sleep Dysfunction 3 3
Granuloma 3 3
Nausea 3 3
Neurological Deficit/Dysfunction 3 3
Arthritis 3 3
Eye Injury 3 3
Fatigue 3 3
Emotional Changes 2 2
Fall 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Bioplate Inc II Nov-01-2011
2 Biomet Microfixation, Inc. II May-27-2011
3 Biomet Microfixation, Inc. II Oct-20-2010
4 Biomet Microfixation, Inc. III Jun-30-2010
5 Biomet Microfixation, Inc. III Mar-17-2010
6 Biomet Microfixation, LLC II Mar-23-2012
7 Biomet, Inc. II Dec-17-2020
8 Materialise N.V. II Aug-03-2023
9 Materialise N.V. II Apr-06-2020
10 Stryker Craniomaxillofacial Division II Dec-16-2010
11 Synthes (USA) Products LLC II Jun-07-2016
12 Synthes (USA) Products LLC II Jul-28-2015
13 Synthes Produktions GmbH II Jul-30-2020
14 Synthes USA (HQ), Inc. II Oct-26-2009
15 Synthes USA HQ, Inc. II Mar-12-2013
16 Synthes, Inc. II Jul-24-2020
17 Walter Lorenz Surgical, Inc. II Jan-11-2012
18 Zimmer Biomet, Inc. II May-07-2018
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