TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	2
CIRCUMFIX SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GM DOS REIS INDUSTRIA E COMERCIO LTDA.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
NEOS SURGERY S.L
	SUBSTANTIALLY EQUIVALENT	2
RIVERPOINT MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	175	175
Mechanical Problem	173	173
Break	143	144
Fracture	30	30
Device-Device Incompatibility	25	25
Device Slipped	20	20
Migration	16	16
Material Deformation	12	12
Insufficient Information	8	8
Crack	6	6
Mechanical Jam	4	4
No Apparent Adverse Event	4	4
Failure to Cut	4	4
Material Fragmentation	4	4
Material Frayed	3	3
Appropriate Term/Code Not Available	3	3
Material Separation	3	3
Therapeutic or Diagnostic Output Failure	3	3
Device Appears to Trigger Rejection	2	2
Device Dislodged or Dislocated	2	2
Detachment of Device or Device Component	2	2
Failure to Osseointegrate	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Patient Device Interaction Problem	2	2
Patient-Device Incompatibility	2	2
Entrapment of Device	2	2
Unraveled Material	1	1
Degraded	1	1
Product Quality Problem	1	1
Material Integrity Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Defective Device	1	1
Defective Component	1	1
Material Disintegration	1	1
Physical Resistance/Sticking	1	1
Nonstandard Device	1	1
Malposition of Device	1	1
Naturally Worn	1	1
Improper or Incorrect Procedure or Method	1	1
Loss of Osseointegration	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	316	316
Unspecified Infection	69	69
Non-union Bone Fracture	54	54
Insufficient Information	48	48
Pain	42	42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	23
Failure of Implant	19	19
Metal Related Pathology	11	11
Post Operative Wound Infection	10	10
Hypersensitivity/Allergic reaction	9	9
Hemorrhage/Bleeding	9	9
Fall	9	9
Unspecified Tissue Injury	7	7
Fluid Discharge	7	7
Discomfort	7	7
Hip Fracture	6	6
Sepsis	6	6
Inflammation	6	6
Adhesion(s)	6	6
Malunion of Bone	6	6
Loss of Range of Motion	6	6
Hematoma	5	5
Bone Fracture(s)	5	5
Swelling/ Edema	5	5
Joint Dislocation	4	4
Pneumonia	4	4
Impaired Healing	3	3
Bacterial Infection	3	3
Inadequate Osseointegration	3	3
Arthritis	2	2
Joint Contracture	2	2
Joint Laxity	2	2
Scar Tissue	2	2
Muscular Rigidity	2	2
Nerve Damage	2	2
Foreign Body In Patient	2	2
Foreign Body Reaction	2	2
Ossification	2	2
Cellulitis	2	2
Wound Dehiscence	2	2
Pleural Effusion	1	1
Osteolysis	1	1
Chest Pain	1	1
Balance Problems	1	1
Burn(s)	1	1
Abscess	1	1
Post Traumatic Wound Infection	1	1
Muscle/Tendon Damage	1	1
Blister	1	1
Osteopenia/ Osteoporosis	1	1