TPLC - Total Product Life Cycle

show TPLC since

Premarket Reviews
Manufacturer	Decision
A&E MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX, INC
	SUBSTANTIALLY EQUIVALENT	1
CIRCUMFIX SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
GM DOS REIS INDUSTRIA E COMERCIO LTDA.
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
NEOS SURGERY SL
	SUBSTANTIALLY EQUIVALENT	2
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
	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	182	182
Mechanical Problem	174	174
Break	173	173
Fracture	34	34
Device-Device Incompatibility	33	33
Migration	24	24
Device Slipped	19	19
Insufficient Information	16	16
Material Deformation	12	12
No Apparent Adverse Event	6	6
Crack	6	6
Failure to Cut	5	5
Material Fragmentation	5	5
Migration or Expulsion of Device	5	5
Material Frayed	5	5
Appropriate Term/Code Not Available	4	4
Material Separation	3	3
Entrapment of Device	3	3
Defective Component	2	2
Material Integrity Problem	2	2
Patient Device Interaction Problem	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Patient-Device Incompatibility	2	2
Failure to Osseointegrate	2	2
Product Quality Problem	2	2
Detachment of Device or Device Component	2	2
Device Appears to Trigger Rejection	2	2
Unintended Movement	1	1
Defective Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
No Fail-Safe Mechanism	1	1
Therapeutic or Diagnostic Output Failure	1	1
Degraded	1	1
Unraveled Material	1	1
Device Difficult to Setup or Prepare	1	1
Material Disintegration	1	1
Physical Resistance/Sticking	1	1
Malposition of Device	1	1
Device Contamination with Chemical or Other Material	1	1
Device Dislodged or Dislocated	1	1
Nonstandard Device	1	1
Connection Problem	1	1
Naturally Worn	1	1
Improper or Incorrect Procedure or Method	1	1
Mechanical Jam	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	291	291
Unspecified Infection	80	80
Non-union Bone Fracture	53	53
Pain	49	49
Insufficient Information	47	47
No Code Available	37	37
Failure of Implant	33	33
No Consequences Or Impact To Patient	27	27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Post Operative Wound Infection	14	14
No Known Impact Or Consequence To Patient	13	13
No Patient Involvement	11	11
Metal Related Pathology	11	11
Bone Fracture(s)	11	11
Hypersensitivity/Allergic reaction	10	10
Fall	9	9
Discomfort	8	8
Hemorrhage/Bleeding	7	7
Unspecified Tissue Injury	7	7
Fluid Discharge	6	6
Death	6	6
Hip Fracture	6	6
Malunion of Bone	6	6
Adhesion(s)	6	6
Sepsis	5	5
Inflammation	5	5
Loss of Range of Motion	5	5
Foreign Body In Patient	5	5
Swelling/ Edema	5	5
Pneumonia	4	4
Injury	4	4
Bacterial Infection	4	4
Hematoma	4	4
Ossification	3	3
Inadequate Osseointegration	3	3
Joint Dislocation	3	3
Impaired Healing	3	3
Foreign Body Reaction	2	2
Cellulitis	2	2
Joint Contracture	2	2
Nerve Damage	2	2
Joint Laxity	2	2
Edema	2	2
Scar Tissue	2	2
Wound Dehiscence	2	2
Tissue Damage	1	1
Erosion	1	1
Muscle/Tendon Damage	1	1
Fibrosis	1	1
Arthritis	1	1