TPLC - Total Product Life Cycle

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Device	driver, wire, and bone drill, manual
Product Code	DZJ
Regulation Number	872.4120
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	401	401
Device Displays Incorrect Message	72	72
Break	32	32
Unintended Power Up	27	37
Device Remains Activated	26	33
Unintended System Motion	17	17
Fluid/Blood Leak	10	10
Adverse Event Without Identified Device or Use Problem	10	10
Smoking	9	9
Unintended Movement	9	9
Detachment of Device or Device Component	8	8
Patient-Device Incompatibility	7	7
Electrical /Electronic Property Problem	6	6
Cut In Material	5	5
Device-Device Incompatibility	5	5
Device Operates Differently Than Expected	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Physical Resistance/Sticking	5	7
Entrapment of Device	5	5
Malposition of Device	5	5
Inadequacy of Device Shape and/or Size	4	4
Crack	4	4
Patient Device Interaction Problem	3	3
Inaccurate Information	3	3
Device Markings/Labelling Problem	3	3
Insufficient Information	2	2
Labelling, Instructions for Use or Training Problem	2	2
Peeled/Delaminated	2	2
Mechanical Problem	2	2
Inadequate Instructions for Healthcare Professional	1	1
Difficult to Insert	1	1
Device Difficult to Setup or Prepare	1	1
Incorrect Device Or Component Shipped	1	1
Positioning Failure	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Failure to Cut	1	1
Mechanics Altered	1	1
Difficult to Remove	1	1
Improper or Incorrect Procedure or Method	1	1
Image Display Error/Artifact	1	1
No Apparent Adverse Event	1	1
Product Quality Problem	1	1
Defective Device	1	1
Disassembly	1	1
Unstable	1	1
Fracture	1	1
Compatibility Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	299	309
No Patient Involvement	252	261
No Clinical Signs, Symptoms or Conditions	65	83
No Known Impact Or Consequence To Patient	25	25
No Information	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
No Code Available	5	5
Foreign Body In Patient	4	4
Insufficient Information	4	4
Joint Dislocation	3	3
Burn(s)	3	3
Failure of Implant	2	2
Therapeutic Effects, Unexpected	2	2
Hematoma	1	1
Tooth Fracture	1	1
Nerve Damage	1	1
Loss of Range of Motion	1	1
Sedation	1	1
Malunion of Bone	1	1
Pulmonary Edema	1	1
Cancer	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medical Modeling, Inc.	II	Aug-09-2022
2	Stryker Instruments Div. of Stryker Corporation	II	Oct-28-2013
3	Stryker Instruments Div. of Stryker Corporation	II	Nov-16-2011