TPLC - Total Product Life Cycle

show TPLC since

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	25	28
Break	21	21
Detachment of Device or Device Component	17	20
Insufficient Device Problem Information	16	16
Positioning Failure	10	10
Patient Device Interaction Problem	7	9
Device Slipped	6	6
Material Split, Cut or Torn	6	6
Device Fell	6	9
Component Missing	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Fracture	6	6
Material Twisted/Bent	5	5
Mechanical Problem	4	4
Naturally Worn	4	7
Difficult to Open or Close	4	4
Device Dislodged or Dislocated	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
Material Separation	1	1
Loose or Intermittent Connection	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	91	93
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
Muscle Weakness/Atrophy	2	2
No Information	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