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
Unintended Movement	9	9
Smoking	9	9
Detachment of Device or Device Component	8	8
Patient-Device Incompatibility	7	7
Electrical /Electronic Property Problem	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Device Operates Differently Than Expected	5	5
Cut In Material	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Entrapment of Device	5	5
Physical Resistance/Sticking	5	7
Device-Device Incompatibility	5	5
Inadequacy of Device Shape and/or Size	4	4
Malposition of Device	4	4
Crack	4	4
Device Markings/Labelling Problem	3	3
Inaccurate Information	3	3
Patient Device Interaction Problem	3	3
Peeled/Delaminated	2	2
Mechanical Problem	2	2
Insufficient Information	2	2
Labelling, Instructions for Use or Training Problem	2	2
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Defective Device	1	1
Difficult to Insert	1	1
Mechanics Altered	1	1
Incorrect Device Or Component Shipped	1	1
Image Display Error/Artifact	1	1
Positioning Failure	1	1
Difficult to Remove	1	1
Fracture	1	1
Product Quality Problem	1	1
Compatibility Problem	1	1
Unstable	1	1
Improper or Incorrect Procedure or Method	1	1
Failure to Cut	1	1
Inadequate Instructions for Healthcare Professional	1	1
Disassembly	1	1
No Apparent Adverse Event	1	1
Device Difficult to Setup or Prepare	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	64	82
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
Burn(s)	3	3
Therapeutic Effects, Unexpected	2	2
Hematoma	1	1
Nerve Damage	1	1
Pulmonary Edema	1	1
Loss of Range of Motion	1	1
Sedation	1	1
Joint Dislocation	1	1
Tooth Fracture	1	1
Device Embedded In Tissue or Plaque	1	1
Cancer	1	1
Malunion of Bone	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