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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device plate, bone
Regulation Description Bone plate.
Product CodeJEY
Regulation Number 872.4760
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 1
FAICO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
INDUSTRIAS MEDICAS SAMPEDRO S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 2
MEDCAD
  SUBSTANTIALLY EQUIVALENT 2
METICULY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MONTJADE ENGINEERING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
REOSS GMBH
  SUBSTANTIALLY EQUIVALENT 1
SITES MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CRANIOMAXILLOFACIAL
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CRANIOMAXILLOFACIAL (CMF)
  SUBSTANTIALLY EQUIVALENT 1
STRYKER LEIBINGER GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
STRYKER LEIBINGER MICRO IMPLANTS
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TECHMAH CMF
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 680 680
2021 451 451
2022 344 344
2023 507 507
2024 696 696
2025 134 134

Device Problems MDRs with this Device Problem Events in those MDRs
Break 872 872
Adverse Event Without Identified Device or Use Problem 700 700
Fracture 353 353
Device-Device Incompatibility 170 170
Material Twisted/Bent 153 153
Material Deformation 100 100
Migration 99 99
Device Slipped 94 94
Manufacturing, Packaging or Shipping Problem 61 61
Loosening of Implant Not Related to Bone-Ingrowth 53 53
Entrapment of Device 43 43
Crack 41 41
Difficult to Advance 31 31
Osseointegration Problem 29 29
Migration or Expulsion of Device 26 26
Defective Device 19 19
Device Dislodged or Dislocated 17 17
Failure to Cut 17 17
Device Appears to Trigger Rejection 16 16
Patient-Device Incompatibility 16 16
Material Integrity Problem 16 16
Patient Device Interaction Problem 16 16
No Apparent Adverse Event 15 15
Device Damaged Prior to Use 15 15
Loss of Osseointegration 14 14
Insufficient Information 14 14
Inadequacy of Device Shape and/or Size 13 13
Detachment of Device or Device Component 12 12
Material Fragmentation 12 12
Noise, Audible 11 11
Packaging Problem 11 11
Malposition of Device 10 10
Difficult to Insert 8 8
Nonstandard Device 7 7
Use of Device Problem 6 6
Failure to Osseointegrate 5 5
Output Problem 5 5
Positioning Problem 4 4
Component Missing 4 4
Device Markings/Labelling Problem 4 4
Dull, Blunt 4 4
Material Frayed 4 4
Difficult or Delayed Positioning 3 3
Tear, Rip or Hole in Device Packaging 3 3
Device Contamination with Body Fluid 3 3
Appropriate Term/Code Not Available 3 3
Improper or Incorrect Procedure or Method 3 3
Mechanical Jam 3 3
Device Contaminated During Manufacture or Shipping 3 3
Biocompatibility 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1115 1115
No Consequences Or Impact To Patient 246 246
Unspecified Infection 240 240
Insufficient Information 180 180
Failure of Implant 151 151
Pain 142 142
Non-union Bone Fracture 127 127
No Code Available 120 120
Foreign Body In Patient 106 106
Impaired Healing 85 85
Swelling/ Edema 75 75
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 73 73
Unspecified Tissue Injury 70 70
No Known Impact Or Consequence To Patient 64 64
Wound Dehiscence 32 32
Nerve Damage 32 32
Physical Asymmetry 32 32
Discomfort 28 28
No Patient Involvement 28 28
Inflammation 26 26
No Information 26 26
Post Operative Wound Infection 23 23
Bacterial Infection 23 23
Inadequate Osseointegration 23 23
Difficulty Chewing 21 21
Confusion/ Disorientation 21 21
Hypersensitivity/Allergic reaction 17 17
Purulent Discharge 16 16
Skin Inflammation/ Irritation 14 14
Bone Fracture(s) 14 14
Cerebrospinal Fluid Leakage 14 14
Loss of Range of Motion 14 14
Headache 14 14
Erythema 14 14
Swelling 13 13
Inadequate Pain Relief 13 13
Limited Mobility Of The Implanted Joint 12 12
Osteolysis 11 11
Implant Pain 11 11
Paralysis 11 11
Paresthesia 10 10
Necrosis 9 9
Fluid Discharge 8 8
Foreign Body Reaction 8 8
Device Embedded In Tissue or Plaque 8 8
Difficulty Chewing 6 6
Fistula 6 6
Obstruction/Occlusion 6 6
Hematoma 6 6
Ossification 5 5

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
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