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TPLC
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show TPLC since
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Device
hearing aid, bone conduction
Product Code
LXB
Regulation Number
874.3302
Device Class
2
Premarket Reviews
Manufacturer
Decision
COCHLEAR AMERICAS
SUBSTANTIALLY EQUIVALENT
2
OTICON MEDICAL AB
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2019
497
497
2020
547
547
2021
490
490
2022
387
387
2023
355
355
2024
65
65
Device Problems
MDRs with this Device Problem
Events in those MDRs
Appropriate Term/Code Not Available
1098
1098
Adverse Event Without Identified Device or Use Problem
448
448
Patient Device Interaction Problem
344
344
Loss of Osseointegration
292
292
Insufficient Information
72
72
Expulsion
33
33
Biocompatibility
20
20
Patient-Device Incompatibility
18
18
Failure to Osseointegrate
17
17
Inadequacy of Device Shape and/or Size
16
16
No Apparent Adverse Event
8
8
Device Appears to Trigger Rejection
7
7
Signal Artifact/Noise
6
6
Output Problem
5
5
Therapeutic or Diagnostic Output Failure
4
4
Loosening of Implant Not Related to Bone-Ingrowth
4
4
Device Dislodged or Dislocated
4
4
Thermal Decomposition of Device
2
2
Failure to Deliver Shock/Stimulation
2
2
Unexpected Therapeutic Results
2
2
Use of Device Problem
2
2
Migration
2
2
Misassembly During Maintenance/Repair
2
2
Material Integrity Problem
2
2
Material Protrusion/Extrusion
1
1
Osseointegration Problem
1
1
Defective Component
1
1
Overheating of Device
1
1
Detachment of Device or Device Component
1
1
Battery Problem
1
1
Malposition of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
377
377
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
313
313
No Clinical Signs, Symptoms or Conditions
233
233
No Code Available
203
203
Pain
190
190
Skin Infection
154
154
Inadequate Osseointegration
136
136
Patient Problem/Medical Problem
125
125
Impaired Healing
112
112
Host-Tissue Reaction
101
101
Skin Inflammation/ Irritation
72
72
Insufficient Information
71
71
Tissue Breakdown
58
58
Discomfort
52
52
Bacterial Infection
49
49
Implant Pain
46
46
Cellulitis
31
31
Hearing Impairment
30
30
No Information
28
28
Scar Tissue
24
24
Head Injury
23
23
Headache
23
23
Skin Irritation
22
22
Purulent Discharge
19
19
Fluid Discharge
18
18
Swelling/ Edema
15
15
Post Operative Wound Infection
14
14
Swelling
14
14
Necrosis
13
13
Inflammation
12
12
Wound Dehiscence
12
12
Skin Disorders
11
11
Erythema
11
11
Necrosis Of Flap Tissue
8
8
Hemorrhage/Bleeding
6
6
Skin Inflammation
6
6
Failure of Implant
5
5
Foreign Body Reaction
5
5
Hematoma
4
4
Burning Sensation
4
4
No Consequences Or Impact To Patient
4
4
No Known Impact Or Consequence To Patient
4
4
Missing Value Reason
3
3
Dizziness
3
3
Therapeutic Response, Decreased
2
2
Ulcer
2
2
Pressure Sores
2
2
Seroma
2
2
Skin Erosion
2
2
Granuloma
2
2
Fall
2
2
Fistula
2
2
Abscess
2
2
Osteomyelitis
2
2
Increased Sensitivity
2
2
Skin Burning Sensation
2
2
Electric Shock
2
2
No Patient Involvement
2
2
Injury
2
2
Scar Excision
2
2
Solid Tumour
2
2
Meningitis
1
1
Autoimmune Disorder
1
1
Ossification
1
1
Irritation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cochlear Americas Inc.
II
Jan-24-2020
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