TPLC - Total Product Life Cycle

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Device	table and attachments, operating-room
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	32	32
Insufficient Information	20	20
Unintended Movement	16	16
Detachment of Device or Device Component	14	14
Mechanical Problem	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Material Split, Cut or Torn	8	8
Device Fell	7	7
Break	6	6
Patient Device Interaction Problem	5	5
Positioning Failure	4	4
Improper or Incorrect Procedure or Method	3	3
Component Missing	3	3
Material Twisted/Bent	3	3
Device Slipped	2	2
Device Dislodged or Dislocated	2	2
Human-Device Interface Problem	2	2
Fracture	2	2
Sharp Edges	2	2
Physical Resistance/Sticking	1	1
No Apparent Adverse Event	1	1
Device Handling Problem	1	1
Component Falling	1	1
Structural Problem	1	1
Unstable	1	1
Mechanical Jam	1	1
Positioning Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	41	41
Laceration(s)	14	14
Insufficient Information	11	11
Unspecified Tissue Injury	9	9
Injury	8	8
Bone Fracture(s)	6	6
Abrasion	4	4
Numbness	4	4
Pain	4	4
Hematoma	4	4
Ulcer	4	4
No Information	4	4
Limb Fracture	4	4
No Consequences Or Impact To Patient	3	3
Skin Tears	2	2
No Known Impact Or Consequence To Patient	2	2
Fall	2	2
Muscle Weakness	2	2
Nerve Damage	2	2
Head Injury	2	2
Headache	1	1
Hair Loss	1	1

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