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TPLC
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Device
table, surgical with orthopedic accessories, ac-powered
Product Code
JEA
Regulation Number
878.4960
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
63
63
2020
46
46
2021
40
40
2022
32
32
2023
34
34
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
53
53
Insufficient Information
27
27
Adverse Event Without Identified Device or Use Problem
23
23
Use of Device Problem
22
22
Unintended System Motion
15
15
Device Slipped
15
15
Improper or Incorrect Procedure or Method
12
12
Device Fell
11
11
Mechanical Problem
9
9
Detachment of Device or Device Component
8
8
Device Dislodged or Dislocated
8
8
Unexpected Shutdown
8
8
Electrical Shorting
6
6
Fracture
5
5
Positioning Problem
5
5
Device Handling Problem
4
4
Loss of or Failure to Bond
4
4
Crack
4
4
Patient-Device Incompatibility
4
4
Smoking
3
3
Break
3
3
Misassembly by Users
3
3
No Apparent Adverse Event
3
3
Output Problem
3
3
Communication or Transmission Problem
2
2
Patient Device Interaction Problem
2
2
Malposition of Device
2
2
Circuit Failure
2
2
Inadequate Instructions for Healthcare Professional
2
2
Loose or Intermittent Connection
2
2
Intermittent Continuity
2
2
Electrical /Electronic Property Problem
2
2
Overheating of Device
2
2
Corroded
2
2
Unintended Collision
2
2
Material Separation
1
1
Defective Component
1
1
Component Missing
1
1
Structural Problem
1
1
Application Program Problem
1
1
Battery Problem
1
1
Mechanical Jam
1
1
Entrapment of Device
1
1
Fire
1
1
Use of Incorrect Control/Treatment Settings
1
1
Misconnection
1
1
Moisture Damage
1
1
Collapse
1
1
Computer Software Problem
1
1
Degraded
1
1
Positioning Failure
1
1
Disconnection
1
1
Failure to Clean Adequately
1
1
Key or Button Unresponsive/not Working
1
1
Unintended Electrical Shock
1
1
Physical Resistance/Sticking
1
1
Noise, Audible
1
1
Wireless Communication Problem
1
1
Connection Problem
1
1
Power Problem
1
1
Protective Measures Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
65
65
No Known Impact Or Consequence To Patient
52
52
Fall
44
44
Insufficient Information
18
18
Pressure Sores
11
11
No Consequences Or Impact To Patient
10
10
Erythema
6
6
Injury
5
5
Skin Tears
5
5
Laceration(s)
5
5
Pain
4
4
Bone Fracture(s)
4
4
Bruise/Contusion
4
4
No Patient Involvement
3
3
Abrasion
3
3
Unintended Extubation
3
3
Muscle/Tendon Damage
2
2
No Information
2
2
Swelling
2
2
Stenosis
2
2
Numbness
2
2
Burn(s)
2
2
Hematoma
2
2
Paralysis
2
2
Damage to Ligament(s)
2
2
Muscle Weakness
1
1
Necrosis
1
1
Nerve Damage
1
1
Perforation
1
1
Skin Irritation
1
1
Hemorrhage, Subarachnoid
1
1
Low Blood Pressure/ Hypotension
1
1
Incontinence
1
1
Irritation
1
1
Cardiac Arrest
1
1
Contusion
1
1
Spinal Cord Injury
1
1
Paraplegia
1
1
Low Oxygen Saturation
1
1
Tissue Breakdown
1
1
Ambulation Difficulties
1
1
Electric Shock
1
1
Extubate
1
1
Concussion
1
1
Arrhythmia
1
1
Bacterial Infection
1
1
No Code Available
1
1
Respiratory Insufficiency
1
1
Limb Fracture
1
1
Vertebral Fracture
1
1
Blister
1
1
Swelling/ Edema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Mizuho OSI
II
Oct-09-2020
2
Steris Corporation
II
Feb-24-2021
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