TPLC - Total Product Life Cycle

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Device	bone fixation cerclage, sublaminar
Definition	Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.
Product Code	OWI
Regulation Number	888.3010
Device Class	2

Premarket Reviews
Manufacturer	Decision
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
COUSIN BIOTECH S.A.S.
	SUBSTANTIALLY EQUIVALENT	2
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
HOGAN LOVELLS US LLP
	SUBSTANTIALLY EQUIVALENT	1
IMPLANET S.A.
	SUBSTANTIALLY EQUIVALENT	2
IMPLANET, S.A.
	SUBSTANTIALLY EQUIVALENT	5
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	3
MEDICREA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL S. A.
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	3
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
ORTHO DEVELOPMENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS CORP.
	SUBSTANTIALLY EQUIVALENT	2
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS INC
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER SPINE
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	14	14
Material Rupture	6	6
Device Damaged by Another Device	6	6
Adverse Event Without Identified Device or Use Problem	4	4
Fracture	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Expulsion	2	2
Material Deformation	2	2
Naturally Worn	2	2
Patient-Device Incompatibility	2	2
Material Split, Cut or Torn	2	2
Appropriate Term/Code Not Available	2	2
No Apparent Adverse Event	1	1
Output above Specifications	1	1
Device Operates Differently Than Expected	1	1
Improper or Incorrect Procedure or Method	1	1
Insufficient Information	1	1
Detachment of Device or Device Component	1	1
Mechanical Problem	1	1
Positioning Failure	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	10	10
No Clinical Signs, Symptoms or Conditions	7	7
Bone Fracture(s)	6	6
Pain	6	6
No Information	5	5
No Code Available	5	5
Patient Problem/Medical Problem	3	3
Neurological Deficit/Dysfunction	3	3
Failure of Implant	3	3
Unspecified Infection	1	1
Inflammation	1	1
Fever	1	1
Spinal Column Injury	1	1
Reaction	1	1
Cancer	1	1
Insufficient Information	1	1