Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
table and attachments, operating-room
Regulation Description
Manual operating table and accessories and manual operating chair and accessories.
Product Code
BWN
Regulation Number
878.4950
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
9
9
2021
16
16
2022
6
6
2023
50
50
2024
50
50
2025
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Use of Device Problem
38
38
Unintended Movement
24
24
Insufficient Information
18
18
Break
17
17
Detachment of Device or Device Component
16
16
Material Split, Cut or Torn
8
8
Positioning Failure
8
8
Device Fell
7
7
Device Slipped
6
6
Component Missing
6
6
Adverse Event Without Identified Device or Use Problem
6
6
Material Twisted/Bent
5
5
Patient Device Interaction Problem
5
5
Naturally Worn
4
4
Device Dislodged or Dislocated
4
4
Mechanical Problem
4
4
Fracture
3
3
Improper or Incorrect Procedure or Method
3
3
Difficult to Open or Close
3
3
Human-Device Interface Problem
2
2
Fitting Problem
2
2
Defective Device
2
2
Battery Problem
1
1
Solder Joint Fracture
1
1
Unstable
1
1
Loose or Intermittent Connection
1
1
Product Quality Problem
1
1
Component Falling
1
1
Contamination
1
1
Crack
1
1
Material Deformation
1
1
Packaging Problem
1
1
Positioning Problem
1
1
Loss of or Failure to Bond
1
1
Physical Resistance/Sticking
1
1
Sharp Edges
1
1
Device Handling Problem
1
1
No Apparent Adverse Event
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
75
75
Insufficient Information
14
14
Laceration(s)
13
13
Unspecified Tissue Injury
9
9
Bone Fracture(s)
6
6
Abrasion
5
5
No Information
4
4
Hematoma
4
4
Injury
4
4
Numbness
4
4
Pain
4
4
Limb Fracture
4
4
Ulcer
4
4
Head Injury
3
3
Fall
3
3
Bruise/Contusion
3
3
Muscle Weakness
2
2
Tooth Fracture
2
2
No Known Impact Or Consequence To Patient
2
2
Nerve Damage
2
2
Skin Tears
2
2
No Consequences Or Impact To Patient
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Innovative Orthopedic Technologies, LLC
II
Oct-07-2021
-
-