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
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
Break	204	204
Mechanical Problem	201	201
Adverse Event Without Identified Device or Use Problem	186	186
Device-Device Incompatibility	39	39
Fracture	35	35
Device Slipped	23	23
Migration	23	23
Insufficient Information	17	17
No Apparent Adverse Event	14	14
Material Deformation	12	12
Material Frayed	8	8
Crack	7	7
Device Difficult to Maintain	6	6
Migration or Expulsion of Device	5	5
Failure to Cut	5	5
Material Fragmentation	5	5
Appropriate Term/Code Not Available	4	4
Material Separation	4	4
Entrapment of Device	3	3
Material Integrity Problem	3	3
Device Appears to Trigger Rejection	2	2
Detachment of Device or Device Component	2	2
Product Quality Problem	2	2
Failure to Osseointegrate	2	2
Use of Device Problem	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Patient Device Interaction Problem	2	2
Defective Component	2	2
Patient-Device Incompatibility	2	2
Unraveled Material	1	1
Device Difficult to Setup or Prepare	1	1
Degraded	1	1
Component Missing	1	1
Therapeutic or Diagnostic Output Failure	1	1
No Fail-Safe Mechanism	1	1
Delivered as Unsterile Product	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Packaging Problem	1	1
Device Handling Problem	1	1
Defective Device	1	1
Unintended Movement	1	1
Device Contamination with Chemical or Other Material	1	1
Material Disintegration	1	1
Physical Resistance/Sticking	1	1
Malposition of Device	1	1
Nonstandard Device	1	1
Material Split, Cut or Torn	1	1
Connection Problem	1	1
Naturally Worn	1	1
Corroded	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	261	261
No Consequences Or Impact To Patient	100	100
No Code Available	85	85
Unspecified Infection	80	80
Pain	54	54
Non-union Bone Fracture	48	48
Failure of Implant	42	42
Insufficient Information	35	35
No Patient Involvement	23	23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Bone Fracture(s)	21	21
No Known Impact Or Consequence To Patient	17	17
Injury	15	15
Hypersensitivity/Allergic reaction	12	12
Post Operative Wound Infection	12	12
Metal Related Pathology	9	9
Inflammation	9	9
Fall	9	9
Wound Dehiscence	7	7
Hemorrhage/Bleeding	7	7
Unspecified Tissue Injury	7	7
Death	6	6
Hip Fracture	6	6
Adhesion(s)	6	6
Hematoma	6	6
Impaired Healing	5	5
Malunion of Bone	5	5
Reaction	5	5
Edema	5	5
Foreign Body In Patient	5	5
Swelling/ Edema	4	4
Discomfort	4	4
Loss of Range of Motion	4	4
Bacterial Infection	3	3
Fluid Discharge	3	3
Not Applicable	3	3
Inadequate Osseointegration	3	3
Joint Dislocation	3	3
Nerve Damage	2	2
Cellulitis	2	2
Ossification	2	2
Scar Tissue	2	2
No Information	2	2
Joint Contracture	2	2
Patient Problem/Medical Problem	2	2
Burn(s)	1	1
Foreign Body Reaction	1	1
Blister	1	1
Muscular Rigidity	1	1
Pleural Effusion	1	1

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