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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 1
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 3
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 1
MATRIX SURGICAL HOLDINGS, LLC/MATRIX SURGICAL USA
  SUBSTANTIALLY EQUIVALENT 1
MCI MEDICAL CONCEPT INNOVATION INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDCAD
  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 4
STRYKER CRANIOMAXILLOFACIAL (CMF)
  SUBSTANTIALLY EQUIVALENT 1
STRYKER LEIBINGER GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
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
2018 607 607
2019 595 595
2020 679 679
2021 451 451
2022 344 344
2023 70 70

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 829 829
Break 755 755
Fracture 328 328
Device-Device Incompatibility 138 138
Device Slipped 108 108
Material Deformation 99 99
Material Twisted/Bent 76 76
Insufficient Information 69 69
Migration 45 45
No Apparent Adverse Event 37 37
Crack 34 34
Difficult to Insert 33 33
Device Appears to Trigger Rejection 28 28
Patient-Device Incompatibility 28 28
Migration or Expulsion of Device 28 28
Osseointegration Problem 27 27
Material Fragmentation 27 27
Patient Device Interaction Problem 24 24
Device Dislodged or Dislocated 24 24
Difficult to Advance 21 21
Manufacturing, Packaging or Shipping Problem 18 18
Unintended Movement 18 18
Failure to Cut 17 17
Material Integrity Problem 17 17
Loosening of Implant Not Related to Bone-Ingrowth 16 16
Entrapment of Device 16 16
Defective Device 15 15
Inadequacy of Device Shape and/or Size 14 14
Detachment of Device or Device Component 13 13
Malposition of Device 12 12
Appropriate Term/Code Not Available 10 10
Biocompatibility 9 9
Packaging Problem 9 9
Noise, Audible 8 8
Detachment Of Device Component 8 8
Use of Device Problem 8 8
Loss of Osseointegration 6 6
Dull, Blunt 6 6
Device Markings/Labelling Problem 5 5
Naturally Worn 5 5
Output Problem 5 5
Mechanical Jam 4 4
Failure to Advance 4 4
Failure to Osseointegrate 4 4
Device Contamination with Body Fluid 3 3
Contamination 3 3
Component Missing 3 3
Material Protrusion/Extrusion 3 3
Device Contaminated During Manufacture or Shipping 3 3
Loose or Intermittent Connection 3 3
Premature Separation 3 3
Positioning Problem 2 2
Device Damaged Prior to Use 2 2
Mechanical Problem 2 2
Nonstandard Device 2 2
Fitting Problem 2 2
Physical Resistance/Sticking 2 2
Incomplete or Inadequate Connection 2 2
Device Issue 2 2
Material Split, Cut or Torn 2 2
Physical Property Issue 2 2
Biofilm coating in Device 2 2
Material Discolored 2 2
Tear, Rip or Hole in Device Packaging 2 2
Improper or Incorrect Procedure or Method 2 2
Device Operates Differently Than Expected 2 2
Human-Device Interface Problem 1 1
Bent 1 1
Difficult to Remove 1 1
Compatibility Problem 1 1
Unstable 1 1
Misconnection 1 1
Product Quality Problem 1 1
Difficult or Delayed Positioning 1 1
Delivered as Unsterile Product 1 1
Occlusion Within Device 1 1
Extrusion 1 1
Device Difficult to Maintain 1 1
Loss of or Failure to Bond 1 1
Disassembly 1 1
Retraction Problem 1 1
Separation Failure 1 1
Off-Label Use 1 1
Material Separation 1 1
Positioning Failure 1 1
Device Handling Problem 1 1
Dent in Material 1 1
Contamination of Device Ingredient or Reagent 1 1
Microbial Contamination of Device 1 1
Failure to Align 1 1
Component Falling 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 496 497
No Clinical Signs, Symptoms or Conditions 462 462
No Consequences Or Impact To Patient 451 451
No Code Available 396 396
Impaired Healing 178 178
Pain 175 175
No Known Impact Or Consequence To Patient 159 159
Failure of Implant 140 140
Foreign Body In Patient 110 110
No Information 74 74
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 62 62
Erosion 54 54
Swelling/ Edema 52 52
Non-union Bone Fracture 52 52
No Patient Involvement 52 52
Bone Fracture(s) 46 46
Insufficient Information 41 41
Device Embedded In Tissue or Plaque 38 38
Wound Dehiscence 29 29
Bacterial Infection 29 29
Hypersensitivity/Allergic reaction 29 29
Swelling 29 29
Purulent Discharge 28 28
Nerve Damage 25 25
Post Operative Wound Infection 22 22
Ossification 21 21
Injury 21 21
Discomfort 20 20
Cerebrospinal Fluid Leakage 20 20
Limited Mobility Of The Implanted Joint 19 19
Inflammation 19 19
Unspecified Tissue Injury 19 19
Difficulty Chewing 18 18
Skin Irritation 18 18
Headache 18 18
Reaction 17 17
Skin Inflammation/ Irritation 14 14
Inadequate Pain Relief 13 13
Physical Asymmetry 13 13
Loss of Range of Motion 12 12
Not Applicable 11 11
Implant Pain 10 10
Difficulty Chewing 10 10
Hematoma 9 9
Abscess 9 9
Fluid Discharge 8 8
Necrosis 8 8
Visual Impairment 8 8
Foreign Body Reaction 8 8
Scar Tissue 8 8
Facial Nerve Paralysis 6 6
Inadequate Osseointegration 5 5
Patient Problem/Medical Problem 5 5
Visual Disturbances 5 5
Numbness 5 5
Itching Sensation 5 5
Erythema 4 4
Local Reaction 4 4
Bruise/Contusion 4 4
Hemorrhage/Bleeding 4 4
Osteolysis 4 4
Joint Dislocation 4 4
Sleep Dysfunction 3 3
Hydrocephalus 3 3
Arthritis 3 3
Hypoesthesia 3 3
Neurological Deficit/Dysfunction 3 3
Feeding Problem 3 3
Hearing Loss 3 3
Cancer 3 3
Perforation 2 2
Rupture 2 2
Fistula 2 2
Granuloma 2 2
Dizziness 2 2
Blood Loss 2 2
Skin Tears 2 2
Debris, Bone Shedding 2 2
Joint Laxity 2 2
Muscle Spasm(s) 2 2
Tissue Damage 2 2
Emotional Changes 2 2
Fatigue 2 2
Tissue Breakdown 2 2
Urticaria 2 2
Eye Injury 2 2
Unspecified Musculoskeletal problem 2 2
Laceration(s) 1 1
Seizures 1 1
Skull Fracture 1 1
Weakness 1 1
Dysphasia 1 1
Anxiety 1 1
Alteration In Body Temperature 1 1
Hearing Impairment 1 1
Infiltration into Tissue 1 1
Perforation of Vessels 1 1
Deformity/ Disfigurement 1 1
Anemia 1 1
Muscular Rigidity 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 Produktions GmbH II Jul-30-2020
4 Synthes, Inc. II Jul-24-2020
5 Zimmer Biomet, Inc. II May-07-2018
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