TPLC - Total Product Life Cycle

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Device	driver, wire, and bone drill, manual
Regulation Description	Bone cutting instrument and accessories.
Product Code	DZJ
Regulation Number	872.4120
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	25	25
Adverse Event Without Identified Device or Use Problem	20	20
Device Remains Activated	10	17
Unintended Power Up	8	17
Inadequacy of Device Shape and/or Size	7	7
Patient-Device Incompatibility	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Device-Device Incompatibility	5	5
Entrapment of Device	5	5
Malposition of Device	5	5
Physical Resistance/Sticking	5	7
Patient Device Interaction Problem	3	3
Inaccurate Information	3	3
Device Markings/Labelling Problem	2	2
Defective Device	2	2
Labelling, Instructions for Use or Training Problem	2	2
Compatibility Problem	1	1
Output Problem	1	1
Insufficient Information	1	1
Positioning Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Positioning Failure	1	1
Device Difficult to Setup or Prepare	1	1
Failure to Cut	1	1
Product Quality Problem	1	1
Material Separation	1	1
No Apparent Adverse Event	1	1
Fracture	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	80	98
Insufficient Information	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
No Consequences Or Impact To Patient	5	14
No Patient Involvement	4	13
Foreign Body In Patient	3	3
Joint Dislocation	3	3
Failure of Implant	2	2
No Code Available	2	2
Loss of Range of Motion	2	2
Malunion of Bone	1	1
Device Embedded In Tissue or Plaque	1	1
Laceration(s)	1	1
Nerve Damage	1	1
Tooth Fracture	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medical Modeling, Inc.	II	Aug-09-2022