TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ADVANCED RESEARCH MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
AEGIS SPINE
	SUBSTANTIALLY EQUIVALENT	1
BIOFUSION MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
CAMBER SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
CHOICESPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
COORSTEK MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	1
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
CUTTING EDGE SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
GENESYS SPINE
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
HUVEXEL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ILION MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
L&K BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	2
LIFE SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	3
MEDTRONIC SOFAMOR DANEK
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX INC.
	SUBSTANTIALLY EQUIVALENT	5
ORTHOFUNDAMENTALS, LLC
	SUBSTANTIALLY EQUIVALENT	1
OSSEUS FUSION SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
SI-BONE, INC
	SUBSTANTIALLY EQUIVALENT	1
SI-BONE, INC.
	SUBSTANTIALLY EQUIVALENT	6
SICAGE LLC
	SUBSTANTIALLY EQUIVALENT	1
SIJ SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
SPINUS INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
TENON MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Malposition of Device	516	516
Adverse Event Without Identified Device or Use Problem	255	255
Loss of Osseointegration	99	99
Inadequacy of Device Shape and/or Size	53	53
Failure to Osseointegrate	19	19
Insufficient Information	12	12
Appropriate Term/Code Not Available	6	6
Break	6	6
Migration or Expulsion of Device	6	6
Use of Device Problem	4	4
Patient-Device Incompatibility	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Migration	3	3
Difficult to Advance	2	2
Patient Device Interaction Problem	2	2
Device Operates Differently Than Expected	2	2
Improper or Incorrect Procedure or Method	2	2
Fitting Problem	2	2
Fracture	2	2
Device Slipped	1	1
Unstable	1	1
Difficult to Remove	1	1
Entrapment of Device	1	1
Solder Joint Fracture	1	1
Contamination of Device Ingredient or Reagent	1	1
Detachment of Device or Device Component	1	1
Device Markings/Labelling Problem	1	1
Device Damaged by Another Device	1	1
Structural Problem	1	1
Packaging Problem	1	1
Positioning Problem	1	1
Protective Measures Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Device Handling Problem	1	1
Incomplete or Inadequate Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Arthralgia	415	415
Undesired Nerve Stimulation	392	392
Pain	116	116
Joint Disorder	66	66
Nerve Proximity Nos (Not Otherwise Specified)	51	51
Bone Fracture(s)	21	21
Bacterial Infection	11	11
Hematoma	10	10
No Known Impact Or Consequence To Patient	10	10
Hemorrhage/Bleeding	9	9
No Code Available	8	8
Cellulitis	7	7
Fall	6	6
Patient Problem/Medical Problem	6	6
No Information	6	6
Hypersensitivity/Allergic reaction	5	5
Failure of Implant	4	4
Unspecified Infection	3	3
Cardiac Arrest	3	3
Numbness	3	3
Ambulation Difficulties	3	3
Implant Pain	3	3
Insufficient Information	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Osteopenia/ Osteoporosis	2	2
Blood Loss	2	2
Pseudoaneurysm	2	2
Inadequate Pain Relief	2	2
No Consequences Or Impact To Patient	2	2
Discomfort	1	1
Injury	1	1
Disability	1	1
Chest Pain	1	1
Death	1	1
Reaction	1	1
Osteolysis	1	1
Inflammation	1	1
Irritation	1	1
Nerve Damage	1	1
Rash	1	1
Respiratory Distress	1	1
Septic Shock	1	1
Thrombosis	1	1
Perforation of Vessels	1	1
Weakness	1	1
Burning Sensation	1	1
Tingling	1	1
Foreign Body In Patient	1	1
Missing Value Reason	1	1
Malunion of Bone	1	1
Vascular Dissection	1	1