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TPLC
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show TPLC since
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Device
plate, bone
Product Code
JEY
Regulation Number
872.4760
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
2
KLS-MARTIN L.P.
SUBSTANTIALLY EQUIVALENT
3
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
METICULY CO., LTD.
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
7
STRYKER CRANIOMAXILLOFACIAL
SUBSTANTIALLY EQUIVALENT
1
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
2017
568
568
2018
607
607
2019
595
595
2020
680
680
2021
451
451
2022
344
344
2023
509
509
2024
141
141
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1151
1151
Break
985
985
Fracture
518
518
Device-Device Incompatibility
158
158
Material Deformation
142
142
Device Slipped
122
122
Insufficient Information
103
103
Migration
97
97
Material Twisted/Bent
97
97
Migration or Expulsion of Device
55
55
Loosening of Implant Not Related to Bone-Ingrowth
49
49
No Apparent Adverse Event
43
43
Material Fragmentation
42
42
Difficult to Insert
37
37
Crack
36
36
Inadequacy of Device Shape and/or Size
36
36
Osseointegration Problem
36
36
Patient-Device Incompatibility
35
35
Difficult to Advance
34
34
Entrapment of Device
33
33
Device Appears to Trigger Rejection
31
31
Device Dislodged or Dislocated
30
30
Manufacturing, Packaging or Shipping Problem
29
29
Patient Device Interaction Problem
26
26
Unintended Movement
26
26
Defective Device
21
21
Detachment Of Device Component
19
19
Material Integrity Problem
19
19
Failure to Cut
18
18
Detachment of Device or Device Component
18
18
Malposition of Device
17
17
Appropriate Term/Code Not Available
16
16
Material Protrusion/Extrusion
15
15
Device Operates Differently Than Expected
15
15
Noise, Audible
13
13
Device Markings/Labelling Problem
13
13
Device Inoperable
13
13
Use of Device Problem
12
12
Device Damaged Prior to Use
12
12
Loose or Intermittent Connection
12
12
Packaging Problem
12
12
Dull, Blunt
10
10
Loss of Osseointegration
10
10
Biocompatibility
9
9
Failure to Advance
7
7
Nonstandard Device
7
7
Naturally Worn
7
7
Positioning Problem
7
7
Fitting Problem
6
6
Component Missing
5
5
Failure to Osseointegrate
5
5
Improper or Incorrect Procedure or Method
5
5
Expulsion
5
5
Contamination
5
5
Output Problem
5
5
Mechanical Jam
4
4
Material Frayed
4
4
Failure To Adhere Or Bond
4
4
Tear, Rip or Hole in Device Packaging
4
4
Device Contamination with Body Fluid
3
3
Connection Problem
3
3
Bent
3
3
Component Falling
3
3
Material Discolored
3
3
Positioning Failure
3
3
Product Quality Problem
3
3
Material Separation
3
3
Device Contaminated During Manufacture or Shipping
3
3
Physical Resistance/Sticking
3
3
Premature Separation
3
3
Incomplete or Inadequate Connection
2
2
Material Split, Cut or Torn
2
2
Device Operational Issue
2
2
Physical Property Issue
2
2
Difficult to Remove
2
2
Difficult To Position
2
2
Off-Label Use
2
2
Mechanical Problem
2
2
Difficult or Delayed Positioning
2
2
Biofilm coating in Device
2
2
Activation, Positioning or Separation Problem
2
2
Device Issue
2
2
Sticking
2
2
Unstable
1
1
Microbial Contamination of Device
1
1
Malfunction
1
1
Structural Problem
1
1
Failure to Align
1
1
Extrusion
1
1
Human-Device Interface Problem
1
1
Compatibility Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Dent in Material
1
1
Separation Failure
1
1
Loss of or Failure to Bond
1
1
Disassembly
1
1
Misconnection
1
1
Delivered as Unsterile Product
1
1
Occlusion Within Device
1
1
Peeled/Delaminated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
656
656
No Code Available
583
583
Unspecified Infection
553
554
No Consequences Or Impact To Patient
469
469
No Known Impact Or Consequence To Patient
316
316
Pain
217
217
Failure of Implant
213
213
Impaired Healing
199
199
Foreign Body In Patient
162
162
Non-union Bone Fracture
148
148
Insufficient Information
137
137
No Information
134
134
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
71
71
Swelling/ Edema
70
70
No Patient Involvement
67
67
Unspecified Tissue Injury
58
58
Erosion
56
56
Bone Fracture(s)
53
53
Device Embedded In Tissue or Plaque
49
49
Wound Dehiscence
42
42
Hypersensitivity/Allergic reaction
40
40
Swelling
37
37
Reaction
34
34
Limited Mobility Of The Implanted Joint
31
31
Discomfort
29
29
Bacterial Infection
29
29
Purulent Discharge
28
28
Ossification
28
28
Nerve Damage
28
28
Post Operative Wound Infection
27
27
Inflammation
26
26
Headache
26
26
Cerebrospinal Fluid Leakage
24
24
Difficulty Chewing
23
23
Confusion/ Disorientation
21
21
Injury
21
21
Skin Irritation
20
20
Physical Asymmetry
20
20
Difficulty Chewing
19
19
Loss of Range of Motion
18
18
Hematoma
15
15
Skin Inflammation/ Irritation
14
14
Inadequate Pain Relief
13
13
Osteolysis
13
13
Inadequate Osseointegration
12
12
Foreign Body Reaction
12
12
Infiltration into Tissue
12
12
Necrosis
12
12
Scar Tissue
12
12
Not Applicable
11
11
Implant Pain
11
11
Abscess
10
10
Facial Nerve Paralysis
9
9
Visual Impairment
9
9
Numbness
8
8
Fluid Discharge
8
8
Fistula
7
7
Itching Sensation
5
5
Hemorrhage/Bleeding
5
5
Patient Problem/Medical Problem
5
5
Joint Dislocation
5
5
Visual Disturbances
5
5
Tinnitus
4
4
Cancer
4
4
Local Reaction
4
4
Erythema
4
4
Bruise/Contusion
4
4
Eye Pain
4
4
Malunion of Bone
3
3
Unspecified Musculoskeletal problem
3
3
Arthritis
3
3
Granuloma
3
3
Fatigue
3
3
Feeding Problem
3
3
Staphylococcus Aureus
3
3
Hearing Loss
3
3
Neurological Deficit/Dysfunction
3
3
Hydrocephalus
3
3
Sleep Dysfunction
3
3
Vomiting
3
3
Stenosis
3
3
Hypoesthesia
3
3
Deformity/ Disfigurement
3
3
Urticaria
2
2
Rupture
2
2
Dizziness
2
2
Tissue Damage
2
2
Skin Tears
2
2
Blood Loss
2
2
Sweating
2
2
Cognitive Changes
2
2
Tissue Breakdown
2
2
Joint Laxity
2
2
Muscle Spasm(s)
2
2
Perforation
2
2
Seizures
2
2
Skin Erosion
2
2
Skull Fracture
2
2
Debris, Bone Shedding
2
2
Eye Injury
2
2
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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