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	35	35
Unintended Movement	23	23
Insufficient Information	18	18
Break	16	16
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
Patient Device Interaction Problem	5	5
Mechanical Problem	4	4
Material Twisted/Bent	4	4
Device Dislodged or Dislocated	4	4
Naturally Worn	4	4
Difficult to Open or Close	3	3
Improper or Incorrect Procedure or Method	3	3
Fitting Problem	2	2
Defective Device	2	2
Fracture	2	2
Human-Device Interface Problem	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
No Apparent Adverse Event	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	73	73
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