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

Premarket Reviews
Manufacturer	Decision
3D LIFEPRINTS UK LTD.
	SUBSTANTIALLY EQUIVALENT	1
3D SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
CENTERMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K201353 CenterMed Patient Matched Assisted Surgical Planni ...
DENTAL WINGS GMBH
	SUBSTANTIALLY EQUIVALENT	1
IMMERSIVETOUCH
	SUBSTANTIALLY EQUIVALENT	1
MATERIALISE NV
	SUBSTANTIALLY EQUIVALENT	1
MEDCAD
	SUBSTANTIALLY EQUIVALENT	2
OSTEOMED LLC
	SUBSTANTIALLY EQUIVALENT	1
PROTOMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
TECHFIT DIGITAL SURGERY
	SUBSTANTIALLY EQUIVALENT	1
TECHFIT DIGITAL SURGERY INC.
	SUBSTANTIALLY EQUIVALENT	1
TECHMAH CMF
	SUBSTANTIALLY EQUIVALENT	1
VHA DEAN
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	25	25
Adverse Event Without Identified Device or Use Problem	15	15
Device Remains Activated	9	16
Unintended Power Up	8	17
Patient-Device Incompatibility	6	6
Inadequacy of Device Shape and/or Size	6	6
Device-Device Incompatibility	5	5
Entrapment of Device	5	5
Malposition of Device	5	5
Physical Resistance/Sticking	5	7
Manufacturing, Packaging or Shipping Problem	5	5
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
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	72	90
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Insufficient Information	6	6
No Consequences Or Impact To Patient	5	14
No Patient Involvement	4	13
Joint Dislocation	3	3
Foreign Body In Patient	3	3
Failure of Implant	2	2
No Code Available	2	2
Loss of Range of Motion	2	2
Tooth Fracture	1	1
Nerve Damage	1	1
Laceration(s)	1	1
Malunion of Bone	1	1
Device Embedded In Tissue or Plaque	1	1

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