TPLC - Total Product Life Cycle

• Device: pedicle screw placement guide
• Definition: A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans.
• Product Code: PQC
• Regulation Number: 888.3070
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
MEDACTA INERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	2
MIGHTY OAK MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	3

MDR Year	MDR Reports	MDR Events
2018	3	3
2019	4	4
2020	2	2
2021	3	3
2023	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Positioning Failure	4	4
Material Protrusion/Extrusion	3	3
Appropriate Term/Code Not Available	3	3
Adverse Event Without Identified Device or Use Problem	2	2
Difficult to Insert	2	2
Inadequacy of Device Shape and/or Size	2	2
Use of Device Problem	1	1
Failure to Auto Stop	1	1
Positioning Problem	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5	5
No Known Impact Or Consequence To Patient	4	4
No Code Available	1	1
Unspecified Nervous System Problem	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Bone Fracture(s)	1	1
Pain	1	1
Perforation	1	1
Discomfort	1	1
Nervous System Injury	1	1