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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 L.P.
SUBSTANTIALLY EQUIVALENT
2
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
REOSS GMBH
SUBSTANTIALLY EQUIVALENT
1
SITES MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
STRYKER
SUBSTANTIALLY EQUIVALENT
4
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
SYNTHES (USA) PRODUCTS LLC
SUBSTANTIALLY EQUIVALENT
1
SYNTHES (USA) PRODUCTS, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
595
595
2020
679
679
2021
451
451
2022
344
344
2023
508
508
2024
60
60
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
797
797
Break
675
675
Fracture
339
339
Device-Device Incompatibility
145
145
Device Slipped
106
106
Material Deformation
97
97
Material Twisted/Bent
93
93
Migration
93
93
Insufficient Information
42
42
No Apparent Adverse Event
38
38
Crack
35
35
Entrapment of Device
33
33
Difficult to Advance
32
32
Osseointegration Problem
30
30
Device Appears to Trigger Rejection
29
29
Loosening of Implant Not Related to Bone-Ingrowth
27
27
Manufacturing, Packaging or Shipping Problem
26
26
Migration or Expulsion of Device
23
23
Patient Device Interaction Problem
22
22
Patient-Device Incompatibility
21
21
Device Dislodged or Dislocated
20
20
Failure to Cut
17
17
Defective Device
16
16
Material Integrity Problem
16
16
Unintended Movement
15
15
Inadequacy of Device Shape and/or Size
15
15
Material Fragmentation
15
15
Detachment of Device or Device Component
12
12
Difficult to Insert
11
11
Device Damaged Prior to Use
10
10
Noise, Audible
10
10
Packaging Problem
9
9
Malposition of Device
8
8
Loss of Osseointegration
7
7
Appropriate Term/Code Not Available
7
7
Device Markings/Labelling Problem
6
6
Dull, Blunt
6
6
Nonstandard Device
6
6
Component Missing
5
5
Naturally Worn
5
5
Output Problem
5
5
Positioning Problem
4
4
Tear, Rip or Hole in Device Packaging
4
4
Improper or Incorrect Procedure or Method
4
4
Use of Device Problem
4
4
Material Frayed
4
4
Failure to Osseointegrate
3
3
Device Contamination with Body Fluid
3
3
Device Contaminated During Manufacture or Shipping
3
3
Mechanical Jam
3
3
Biocompatibility
3
3
Activation, Positioning or Separation Problem
2
2
Material Separation
2
2
Difficult or Delayed Positioning
2
2
Positioning Failure
2
2
Material Discolored
2
2
Off-Label Use
2
2
Product Quality Problem
2
2
Loose or Intermittent Connection
2
2
Physical Resistance/Sticking
2
2
Incomplete or Inadequate Connection
2
2
Inaccurate Information
1
1
Mechanical Problem
1
1
Misconnection
1
1
Failure to Sense
1
1
Loss of or Failure to Bond
1
1
Fitting Problem
1
1
Microbial Contamination of Device
1
1
Failure to Advance
1
1
Material Protrusion/Extrusion
1
1
Connection Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Expulsion
1
1
Compatibility Problem
1
1
Device Difficult to Maintain
1
1
Material Split, Cut or Torn
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
635
635
Unspecified Infection
383
383
No Consequences Or Impact To Patient
343
343
No Code Available
341
341
Failure of Implant
146
146
Pain
145
145
Impaired Healing
129
129
Insufficient Information
123
123
Non-union Bone Fracture
122
122
Foreign Body In Patient
115
115
No Known Impact Or Consequence To Patient
96
96
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
71
71
Swelling/ Edema
69
69
Unspecified Tissue Injury
55
55
Erosion
55
55
Bone Fracture(s)
44
44
No Patient Involvement
43
43
No Information
38
38
Wound Dehiscence
31
31
Discomfort
28
28
Hypersensitivity/Allergic reaction
27
27
Purulent Discharge
26
26
Bacterial Infection
24
24
Inflammation
24
24
Nerve Damage
21
21
Confusion/ Disorientation
21
21
Post Operative Wound Infection
21
21
Difficulty Chewing
18
18
Swelling
18
18
Injury
17
17
Device Embedded In Tissue or Plaque
17
17
Physical Asymmetry
17
17
Loss of Range of Motion
16
16
Headache
16
16
Skin Inflammation/ Irritation
14
14
Limited Mobility Of The Implanted Joint
13
13
Inadequate Pain Relief
13
13
Cerebrospinal Fluid Leakage
13
13
Skin Irritation
12
12
Reaction
11
11
Difficulty Chewing
10
10
Implant Pain
10
10
Ossification
9
9
Foreign Body Reaction
8
8
Necrosis
8
8
Fluid Discharge
8
8
Osteolysis
8
8
Numbness
7
7
Inadequate Osseointegration
7
7
Hematoma
7
7
Facial Nerve Paralysis
6
6
Scar Tissue
6
6
Visual Disturbances
5
5
Tinnitus
4
4
Local Reaction
4
4
Abscess
4
4
Bruise/Contusion
4
4
Itching Sensation
4
4
Fistula
4
4
Erythema
4
4
Eye Pain
4
4
Unspecified Musculoskeletal problem
3
3
Sleep Dysfunction
3
3
Deformity/ Disfigurement
3
3
Cancer
3
3
Feeding Problem
3
3
Granuloma
3
3
Arthritis
3
3
Neurological Deficit/Dysfunction
3
3
Visual Impairment
3
3
Hypoesthesia
3
3
Stenosis
3
3
Urticaria
2
2
Rupture
2
2
Dizziness
2
2
Perforation
2
2
Skin Erosion
2
2
Fatigue
2
2
Emotional Changes
2
2
Hemorrhage/Bleeding
2
2
Hearing Loss
2
2
Hydrocephalus
2
2
Joint Laxity
2
2
Malunion of Bone
2
2
Skin Tears
2
2
Ambulation Difficulties
1
1
Osteopenia/ Osteoporosis
1
1
Joint Dislocation
1
1
Loss of consciousness
1
1
Obstruction/Occlusion
1
1
Osteomyelitis
1
1
Decreased Sensitivity
1
1
Convulsion/Seizure
1
1
Movement Disorder
1
1
Bruxism
1
1
Suicidal Ideation
1
1
Cough
1
1
Skin Infection
1
1
Increased Appetite
1
1
Muscular Rigidity
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
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