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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 2
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 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
2018 607 607
2019 595 595
2020 679 679
2021 451 451
2022 344 344
2023 462 462

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 964 964
Break 814 814
Fracture 391 391
Device-Device Incompatibility 150 150
Device Slipped 111 111
Material Deformation 102 102
Migration 97 97
Material Twisted/Bent 95 95
Insufficient Information 72 72
No Apparent Adverse Event 39 39
Crack 36 36
Difficult to Insert 34 34
Migration or Expulsion of Device 33 33
Entrapment of Device 31 31
Osseointegration Problem 31 31
Patient-Device Incompatibility 30 30
Difficult to Advance 29 29
Device Appears to Trigger Rejection 29 29
Manufacturing, Packaging or Shipping Problem 28 28
Material Fragmentation 27 27
Device Dislodged or Dislocated 25 25
Loosening of Implant Not Related to Bone-Ingrowth 25 25
Patient Device Interaction Problem 24 24
Inadequacy of Device Shape and/or Size 19 19
Material Integrity Problem 18 18
Unintended Movement 18 18
Failure to Cut 17 17
Defective Device 17 17
Detachment of Device or Device Component 17 17
Malposition of Device 15 15
Appropriate Term/Code Not Available 10 10
Noise, Audible 10 10
Packaging Problem 9 9
Device Damaged Prior to Use 9 9
Biocompatibility 9 9
Loss of Osseointegration 8 8
Detachment Of Device Component 8 8
Use of Device Problem 8 8
Dull, Blunt 6 6
Naturally Worn 5 5
Device Markings/Labelling Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Output Problem 5 5
Tear, Rip or Hole in Device Packaging 4 4
Component Missing 4 4
Failure to Advance 4 4
Mechanical Jam 4 4
Failure to Osseointegrate 4 4
Material Frayed 4 4
Loose or Intermittent Connection 3 3
Contamination 3 3
Device Contaminated During Manufacture or Shipping 3 3
Material Protrusion/Extrusion 3 3
Device Contamination with Body Fluid 3 3
Premature Separation 3 3
Physical Property Issue 2 2
Positioning Problem 2 2
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 2 2
Incomplete or Inadequate Connection 2 2
Device Issue 2 2
Fitting Problem 2 2
Device Operates Differently Than Expected 2 2
Material Discolored 2 2
Mechanical Problem 2 2
Biofilm coating in Device 2 2
Difficult or Delayed Positioning 2 2
Positioning Failure 2 2
Product Quality Problem 2 2
Material Separation 2 2
Nonstandard Device 2 2
Delivered as Unsterile Product 1 1
Occlusion Within Device 1 1
Off-Label Use 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Failure to Sense 1 1
Misconnection 1 1
Unstable 1 1
Disassembly 1 1
Loss of or Failure to Bond 1 1
Component Falling 1 1
Bent 1 1
Expulsion 1 1
Extrusion 1 1
Human-Device Interface Problem 1 1
Compatibility Problem 1 1
Mechanics Altered 1 1
Microbial Contamination of Device 1 1
Dent in Material 1 1
Separation Failure 1 1
Failure to Align 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Handling Problem 1 1
Device Difficult to Maintain 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 600 600
Unspecified Infection 506 507
No Consequences Or Impact To Patient 451 451
No Code Available 396 396
Pain 189 189
Impaired Healing 184 184
No Known Impact Or Consequence To Patient 159 159
Failure of Implant 158 158
Foreign Body In Patient 128 128
Non-union Bone Fracture 121 121
Insufficient Information 104 104
No Information 74 74
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 71 71
Swelling/ Edema 66 66
Erosion 55 55
No Patient Involvement 52 52
Bone Fracture(s) 47 47
Device Embedded In Tissue or Plaque 38 38
Wound Dehiscence 35 35
Hypersensitivity/Allergic reaction 35 35
Unspecified Tissue Injury 33 33
Swelling 29 29
Bacterial Infection 29 29
Purulent Discharge 28 28
Discomfort 28 28
Nerve Damage 26 26
Inflammation 24 24
Headache 24 24
Post Operative Wound Infection 23 23
Injury 21 21
Ossification 21 21
Cerebrospinal Fluid Leakage 20 20
Limited Mobility Of The Implanted Joint 19 19
Difficulty Chewing 18 18
Skin Irritation 18 18
Reaction 17 17
Loss of Range of Motion 16 16
Physical Asymmetry 15 15
Difficulty Chewing 15 15
Skin Inflammation/ Irritation 14 14
Inadequate Pain Relief 13 13
Osteolysis 12 12
Not Applicable 11 11
Implant Pain 10 10
Necrosis 9 9
Abscess 9 9
Hematoma 9 9
Foreign Body Reaction 8 8
Scar Tissue 8 8
Fluid Discharge 8 8
Inadequate Osseointegration 8 8
Visual Impairment 8 8
Numbness 7 7
Facial Nerve Paralysis 6 6
Itching Sensation 5 5
Joint Dislocation 5 5
Visual Disturbances 5 5
Patient Problem/Medical Problem 5 5
Eye Pain 4 4
Local Reaction 4 4
Tinnitus 4 4
Erythema 4 4
Fistula 4 4
Hemorrhage/Bleeding 4 4
Bruise/Contusion 4 4
Arthritis 3 3
Feeding Problem 3 3
Hearing Loss 3 3
Neurological Deficit/Dysfunction 3 3
Unspecified Musculoskeletal problem 3 3
Cancer 3 3
Hydrocephalus 3 3
Hypoesthesia 3 3
Sleep Dysfunction 3 3
Skin Tears 2 2
Blood Loss 2 2
Dizziness 2 2
Skin Erosion 2 2
Deformity/ Disfigurement 2 2
Rupture 2 2
Urticaria 2 2
Tissue Breakdown 2 2
Joint Laxity 2 2
Malunion of Bone 2 2
Perforation 2 2
Muscle Spasm(s) 2 2
Tissue Damage 2 2
Emotional Changes 2 2
Fatigue 2 2
Eye Injury 2 2
Granuloma 2 2
Debris, Bone Shedding 2 2
Cyst(s) 1 1
Burn(s) 1 1
Infarction, Cerebral 1 1
Autoimmune Reaction 1 1
Anemia 1 1
Arrhythmia 1 1
Abrasion 1 1
Host-Tissue Reaction 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
6 Zimmer Biomet, Inc. II May-07-2018
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