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	200	200
Adverse Event Without Identified Device or Use Problem	176	176
Mechanical Problem	166	166
Device-Device Incompatibility	38	38
Fracture	31	31
Migration	23	23
Device Slipped	22	22
Insufficient Information	17	17
No Apparent Adverse Event	12	12
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
Product Quality Problem	2	2
Failure to Osseointegrate	2	2
Use of Device Problem	2	2
Degraded	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
Component Missing	1	1
Therapeutic or Diagnostic Output Failure	1	1
No Fail-Safe Mechanism	1	1
Mechanics Altered	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Delivered as Unsterile Product	1	1
Defective Device	1	1
Packaging Problem	1	1
Device Handling Problem	1	1
Unintended Movement	1	1
Detachment of Device or Device Component	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
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	225	225
No Consequences Or Impact To Patient	100	100
No Code Available	85	85
Unspecified Infection	77	77
Pain	55	55
Non-union Bone Fracture	47	47
Failure of Implant	40	40
Insufficient Information	28	28
No Patient Involvement	23	23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Bone Fracture(s)	20	20
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
Unspecified Tissue Injury	7	7
Metal Related Pathology	7	7
Wound Dehiscence	7	7
Adhesion(s)	6	6
Hematoma	6	6
Hip Fracture	6	6
Death	6	6
Reaction	6	6
Edema	5	5
Impaired Healing	5	5
Foreign Body In Patient	5	5
Malunion of Bone	5	5
Loss of Range of Motion	4	4
Not Applicable	3	3
Hemorrhage/Bleeding	3	3
Bacterial Infection	3	3
Inadequate Osseointegration	3	3
Discomfort	3	3
Joint Dislocation	3	3
Fluid Discharge	3	3
No Information	2	2
Ossification	2	2
Cellulitis	2	2
Joint Contracture	2	2
Swelling/ Edema	2	2
Nerve Damage	2	2
Patient Problem/Medical Problem	2	2
Device Embedded In Tissue or Plaque	1	1
Bruise/Contusion	1	1
Fibrosis	1	1
Tissue Damage	1	1
Joint Laxity	1	1
Muscle/Tendon Damage	1	1

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