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TPLC
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Device
plate, bone
Product Code
JEY
Regulation Number
872.4760
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
1. K222650
Stryker Cutomized Mandible Recon Plate; Stryker Su
...
STRYKER CRANIOMAXILLOFACIAL
SUBSTANTIALLY EQUIVALENT
2
1. K222650
Stryker Cutomized Mandible Recon Plate; Stryker Su
...
STRYKER CRANIOMAXILLOFACIAL (CMF)
SUBSTANTIALLY EQUIVALENT
1
1. K222650
Stryker Cutomized Mandible Recon Plate; Stryker Su
...
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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