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	39	47
Unintended Movement	29	32
Break	20	20
Detachment of Device or Device Component	16	19
Insufficient Information	15	15
Positioning Failure	9	9
Device Fell	7	10
Patient Device Interaction Problem	7	9
Device Slipped	6	6
Component Missing	6	6
Material Split, Cut or Torn	5	5
Material Twisted/Bent	5	5
Mechanical Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Device Dislodged or Dislocated	4	4
Naturally Worn	4	7
Difficult to Open or Close	4	4
Fracture	3	3
Fitting Problem	2	2
Defective Device	2	2
Human-Device Interface Problem	2	2
Premature Separation	2	2
Improper or Incorrect Procedure or Method	2	2
Unstable	1	1
Physical Resistance/Sticking	1	1
Crack	1	1
Positioning Problem	1	1
Contamination	1	1
Battery Problem	1	1
Sharp Edges	1	1
Solder Joint Fracture	1	1
Material Deformation	1	1
Packaging Problem	1	1
Device Handling Problem	1	1
Product Quality Problem	1	1
Loose or Intermittent Connection	1	1
Loss of or Failure to Bond	1	1
Component Falling	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	82	84
Insufficient Information	14	14
Laceration(s)	13	15
Unspecified Tissue Injury	7	7
Bone Fracture(s)	6	6
Abrasion	5	6
Bruise/Contusion	5	7
Hematoma	4	6
Numbness	4	4
Pain	4	6
Limb Fracture	4	6
Ulcer	4	6
Head Injury	3	3
Fall	3	3
No Information	2	2
Muscle Weakness	2	2
Tooth Fracture	2	4
Localized Skin Lesion	2	2
Nerve Damage	2	2
Skin Tears	2	2
No Consequences Or Impact To Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Innovative Orthopedic Technologies, LLC	II	Oct-07-2021