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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
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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