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TPLC
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show TPLC since
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2024
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Device
filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Product Code
NEK
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
6
4
3
4
4
0
MDR Year
MDR Reports
MDR Events
2019
37
37
2020
31
31
2021
23
23
2022
8
8
2023
14
14
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
82
82
Off-Label Use
7
7
Osseointegration Problem
5
5
Insufficient Information
5
5
Appropriate Term/Code Not Available
3
3
Migration or Expulsion of Device
3
3
Failure to Osseointegrate
2
2
Microbial Contamination of Device
2
2
Device Contamination with Chemical or Other Material
1
1
Nonstandard Device
1
1
Break
1
1
Entrapment of Device
1
1
Leak/Splash
1
1
Patient Device Interaction Problem
1
1
Migration
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
51
51
Ambulation Difficulties
11
11
Neuropathy
11
11
Inflammation
11
11
Failure of Implant
10
10
Inadequate Osseointegration
7
7
Unspecified Infection
7
7
Bacterial Infection
6
6
Ossification
6
6
Nausea
5
5
Injury
5
5
Abscess
5
5
Fever
5
5
Wound Dehiscence
5
5
Dysphagia/ Odynophagia
4
4
Insufficient Information
4
4
Swelling/ Edema
4
4
Stenosis
4
4
Burning Sensation
3
3
Cramp(s) /Muscle Spasm(s)
3
3
Sleep Dysfunction
3
3
Swelling
3
3
Seroma
3
3
Non-union Bone Fracture
3
3
Numbness
3
3
Neck Pain
3
3
Fungal Infection
2
2
Cancer
2
2
Fistula
2
2
Nerve Damage
2
2
Paralysis
2
2
Diarrhea
2
2
Osteolysis
2
2
Cellulitis
2
2
Rheumatoid Arthritis
2
2
No Clinical Signs, Symptoms or Conditions
2
2
Weakness
2
2
Reaction
1
1
Respiratory Distress
1
1
Test Result
1
1
Post Operative Wound Infection
1
1
Eye Injury
1
1
Anxiety
1
1
Gastritis
1
1
Fatigue
1
1
Coma
1
1
Lupus
1
1
Muscle Weakness
1
1
Immunodeficiency
1
1
No Known Impact Or Consequence To Patient
1
1
Paresthesia
1
1
Foreign Body Reaction
1
1
No Code Available
1
1
Bone Fracture(s)
1
1
Abdominal Pain
1
1
Disc Impingement
1
1
Unspecified Tissue Injury
1
1
Cyst(s)
1
1
Muscle Spasm(s)
1
1
Chills
1
1
Neurological Deficit/Dysfunction
1
1
Intervertebral Disc Compression or Protrusion
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Low Blood Pressure/ Hypotension
1
1
Hypoesthesia
1
1
Hematoma
1
1
Dyspnea
1
1
Dehydration
1
1
Fluid Discharge
1
1
Blurred Vision
1
1
Unspecified Nervous System Problem
1
1
Disability
1
1
Connective Tissue Disease
1
1
Undesired Nerve Stimulation
1
1
Pneumonia
1
1
Depression
1
1
Scarring
1
1
Purulent Discharge
1
1
Dizziness
1
1
Blood Loss
1
1
Device Embedded In Tissue or Plaque
1
1
Cerebrospinal Fluid Leakage
1
1
Arachnoiditis, Spinal
1
1
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