TPLC - Total Product Life Cycle

• Device: table and attachments, operating-room
• Product Code: BWN
• Regulation Number: 878.4950
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2018	1	1
2019	6	6
2020	9	9
2021	16	16
2022	6	6
2023	31	31

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	21	21
Insufficient Information	14	14
Unintended Movement	12	12
Detachment of Device or Device Component	11	11
Mechanical Problem	8	8
Adverse Event Without Identified Device or Use Problem	7	7
Material Split, Cut or Torn	7	7
Device Fell	7	7
Break	4	4
Positioning Failure	2	2
Device Slipped	2	2
Device Dislodged or Dislocated	2	2
Human-Device Interface Problem	2	2
Material Twisted/Bent	2	2
Sharp Edges	2	2
Device Handling Problem	1	1
Patient Device Interaction Problem	1	1
Mechanical Jam	1	1
Positioning Problem	1	1
No Apparent Adverse Event	1	1
Unstable	1	1
Improper or Incorrect Procedure or Method	1	1
Structural Problem	1	1
Fracture	1	1
Component Falling	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	27	27
Insufficient Information	11	11
Unspecified Tissue Injury	8	8
Laceration(s)	8	8
Injury	8	8
Bone Fracture(s)	5	5
Numbness	4	4
No Information	4	4
Fall	3	3
No Consequences Or Impact To Patient	3	3
Muscle Weakness	2	2
Nerve Damage	2	2
Pain	2	2
Limb Fracture	2	2
Head Injury	2	2
Skin Tears	2	2
No Known Impact Or Consequence To Patient	2	2
Headache	1	1
Abrasion	1	1
Hair Loss	1	1

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