TPLC - Total Product Life Cycle

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Device	instrument, surgical, orthopedic, dc-powered motor and accessory/attachment
Product Code	KIJ
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Disassembly	19	19
Unintended Power Up	16	16
Device-Device Incompatibility	10	10
Battery Problem	9	9
Overheating of Device	9	9
Smoking	8	8
Fluid/Blood Leak	7	7
Unintended Movement	7	7
Leak/Splash	6	6
Break	5	5
Device Operates Differently Than Expected	3	3
Component Missing	3	3
Delayed Charge Time	3	3
Failure to Shut Off	2	2
Metal Shedding Debris	2	2
Device Dislodged or Dislocated	2	2
Failure to Fire	1	1
Fracture	1	1
Detachment Of Device Component	1	1
Component Falling	1	1
Entrapment of Device	1	1
Unintended Ejection	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Bent	1	1
Corroded	1	1
Device Fell	1	1
Insufficient Information	1	1
Failure to Clean Adequately	1	1
Unintended System Motion	1	1
Device Inoperable	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	53	53
No Known Impact Or Consequence To Patient	17	17
No Clinical Signs, Symptoms or Conditions	12	12
No Information	7	7
No Consequences Or Impact To Patient	4	4
Foreign Body In Patient	2	2
Insufficient Information	2	2
Therapeutic Effects, Unexpected	2	2
Burn, Thermal	1	1
Pain	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Instruments Div. of Stryker Corporation	II	Mar-10-2009