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	38	38
Unintended Movement	22	22
Insufficient Information	20	20
Detachment of Device or Device Component	16	16
Break	13	13
Material Split, Cut or Torn	8	8
Positioning Failure	8	8
Mechanical Problem	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Device Fell	7	7
Device Slipped	6	6
Component Missing	6	6
Patient Device Interaction Problem	5	5
Material Twisted/Bent	4	4
Naturally Worn	4	4
Improper or Incorrect Procedure or Method	3	3
Fitting Problem	2	2
Device Dislodged or Dislocated	2	2
Fracture	2	2
Human-Device Interface Problem	2	2
Defective Device	2	2
Sharp Edges	2	2
Unstable	1	1
Crack	1	1
Contamination	1	1
Battery Problem	1	1
Component Falling	1	1
Mechanical Jam	1	1
Loose or Intermittent Connection	1	1
Physical Resistance/Sticking	1	1
Positioning Problem	1	1
Structural Problem	1	1
Solder Joint Fracture	1	1
Packaging Problem	1	1
Material Deformation	1	1
Device Handling Problem	1	1
No Apparent Adverse Event	1	1
Product Quality Problem	1	1
Difficult to Open or Close	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	70	70
Laceration(s)	16	16
Insufficient Information	13	13
Unspecified Tissue Injury	9	9
Injury	8	8
Bone Fracture(s)	6	6
Abrasion	5	5
No Information	4	4
Hematoma	4	4
Numbness	4	4
Pain	4	4
Limb Fracture	4	4
Ulcer	4	4
Fall	3	3
No Consequences Or Impact To Patient	3	3
Head Injury	2	2
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
Bruise/Contusion	2	2
Hair Loss	1	1
Headache	1	1

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