TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
A&E MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX, INC
	SUBSTANTIALLY EQUIVALENT	1
CIRCUMFIX SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	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
Break	187	187
Adverse Event Without Identified Device or Use Problem	165	165
Mechanical Problem	154	154
Device-Device Incompatibility	30	30
Fracture	27	27
Migration	23	23
Device Slipped	21	21
Insufficient Information	17	17
No Apparent Adverse Event	12	12
Material Frayed	8	8
Material Deformation	6	6
Device Difficult to Maintain	6	6
Failure to Cut	5	5
Migration or Expulsion of Device	5	5
Material Separation	4	4
Appropriate Term/Code Not Available	4	4
Material Fragmentation	3	3
Entrapment of Device	3	3
Material Integrity Problem	3	3
Patient-Device Incompatibility	2	2
Defective Component	2	2
Use of Device Problem	2	2
Failure to Osseointegrate	2	2
Degraded	2	2
Product Quality Problem	2	2
Device Appears to Trigger Rejection	2	2
Patient Device Interaction Problem	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Material Split, Cut or Torn	1	1
Physical Resistance/Sticking	1	1
Device Handling Problem	1	1
Packaging Problem	1	1
Temperature Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Unintended Movement	1	1
Delivered as Unsterile Product	1	1
Device Difficult to Setup or Prepare	1	1
Material Disintegration	1	1
Corroded	1	1
Crack	1	1
Loss of or Failure to Bond	1	1
Improper or Incorrect Procedure or Method	1	1
Component Missing	1	1
Loss of Osseointegration	1	1
Defective Device	1	1
Malposition of Device	1	1
Connection Problem	1	1
Detachment of Device or Device Component	1	1
Device Contamination with Chemical or Other Material	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Mechanical Jam	1	1
Naturally Worn	1	1
No Fail-Safe Mechanism	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	211	211
No Consequences Or Impact To Patient	100	100
No Code Available	85	85
Unspecified Infection	70	70
Pain	55	55
Non-union Bone Fracture	44	44
Failure of Implant	38	38
No Patient Involvement	23	23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Bone Fracture(s)	20	20
Insufficient Information	18	18
No Known Impact Or Consequence To Patient	17	17
Injury	15	15
Hypersensitivity/Allergic reaction	12	12
Post Operative Wound Infection	12	12
Inflammation	10	10
Fall	9	9
Metal Related Pathology	7	7
Reaction	6	6
Unspecified Tissue Injury	6	6
Hematoma	6	6
Adhesion(s)	6	6
Wound Dehiscence	6	6
Death	6	6
Edema	5	5
Hip Fracture	5	5
Foreign Body In Patient	5	5
Loss of Range of Motion	4	4
Impaired Healing	4	4
Joint Dislocation	3	3
Bacterial Infection	3	3
Hemorrhage/Bleeding	3	3
Not Applicable	3	3
Malunion of Bone	3	3
Swelling/ Edema	2	2
No Information	2	2
Patient Problem/Medical Problem	2	2
Fluid Discharge	2	2
Joint Contracture	2	2
Ossification	2	2
Nerve Damage	2	2
Osteolysis	1	1
Inadequate Osseointegration	1	1
Osteopenia/ Osteoporosis	1	1
Limited Mobility Of The Implanted Joint	1	1
Sepsis	1	1
Tissue Damage	1	1
Abscess	1	1
Burn(s)	1	1
Cellulitis	1	1
Cyst(s)	1	1
Foreign Body Reaction	1	1
Muscular Rigidity	1	1
Necrosis	1	1
Balance Problems	1	1
Joint Laxity	1	1
Muscle/Tendon Damage	1	1
Blister	1	1
Solid Tumour	1	1
Device Embedded In Tissue or Plaque	1	1
Fibrosis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Alto Development Corp	II	Oct-30-2019