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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 6
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
METICULY 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 3
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
TECHMAH CMF
  SUBSTANTIALLY EQUIVALENT 1
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 509 509
2024 309 309

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1728 1728
Adverse Event Without Identified Device or Use Problem 1645 1645
Fracture 665 665
Insufficient Information 238 238
Device-Device Incompatibility 175 175
Material Deformation 153 153
Device Slipped 145 145
Material Twisted/Bent 104 104
Migration 98 98
Material Fragmentation 97 97
Migration or Expulsion of Device 96 96
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
Inadequacy of Device Shape and/or Size 58 58
Detachment Of Device Component 56 56
Difficult to Insert 55 55
Loosening of Implant Not Related to Bone-Ingrowth 53 53
Manufacturing, Packaging or Shipping Problem 53 53
No Apparent Adverse Event 46 46
Difficult to Advance 41 41
Crack 40 40
Malposition of Device 40 40
Patient-Device Incompatibility 39 39
Osseointegration Problem 38 38
Entrapment of Device 37 37
Detachment of Device or Device Component 35 35
Fitting Problem 34 34
Device Appears to Trigger Rejection 31 31
Patient Device Interaction Problem 26 26
Defective Device 25 25
Device Inoperable 24 24
Difficult to Remove 22 22
Sticking 21 21
Material Integrity Problem 19 19
Failure to Cut 18 18
Dull, Blunt 17 17
Noise, Audible 17 17
Material Protrusion/Extrusion 17 17
Improper or Incorrect Procedure or Method 17 17
Positioning Problem 16 16
Loss of Osseointegration 15 15
Failure To Adhere Or Bond 14 14
Device Markings/Labelling Problem 14 14
Use of Device Problem 13 13
Difficult To Position 13 13
Device Damaged Prior to Use 13 13
Packaging Problem 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 914 915
No Code Available 866 866
No Known Impact Or Consequence To Patient 858 858
No Clinical Signs, Symptoms or Conditions 769 769
No Consequences Or Impact To Patient 542 542
Pain 396 396
Failure of Implant 387 387
Impaired Healing 293 293
Non-union Bone Fracture 215 215
Foreign Body In Patient 212 212
Device Embedded In Tissue or Plaque 211 211
No Information 176 176
Insufficient Information 141 141
No Patient Involvement 87 87
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 73 73
Swelling 73 73
Swelling/ Edema 71 71
Post Operative Wound Infection 71 71
Reaction 67 67
Bone Fracture(s) 67 67
Erosion 58 58
Unspecified Tissue Injury 58 58
Wound Dehiscence 52 52
Hypersensitivity/Allergic reaction 51 51
Infiltration into Tissue 50 50
Discomfort 49 49
Limited Mobility Of The Implanted Joint 48 48
Bacterial Infection 41 41
Headache 37 37
Ossification 35 35
Inflammation 35 35
Nerve Damage 35 35
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
Physical Asymmetry 21 21
Fistula 21 21
Skin Irritation 20 20
Inadequate Osseointegration 20 20
Loss of Range of Motion 20 20
Difficulty Chewing 19 19
Fluid Discharge 18 18
Osteolysis 18 18
Hematoma 17 17
Necrosis 16 16

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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