TPLC - Total Product Life Cycle

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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

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