TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ACUMED LLC
	SUBSTANTIALLY EQUIVALENT	3
AKROS MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	5
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	4
ARTHROSURFACE, INC
	SUBSTANTIALLY EQUIVALENT	1
ARTHROSURFACE, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET MANUFACTURING CORP.
	SUBSTANTIALLY EQUIVALENT	1
BIOPRO, INC.
	SUBSTANTIALLY EQUIVALENT	1
CC-INSTRUMENTS INC
	SUBSTANTIALLY EQUIVALENT	1
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
CORACOID SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CORIN USA
	SUBSTANTIALLY EQUIVALENT	1
CYCLA ORTHOPEDICS LTD
	SUBSTANTIALLY EQUIVALENT	1
DALLEN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	5
GLOBUS MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
GM DOS REIS INDUSTRIA E COMERCIO LTDA
	SUBSTANTIALLY EQUIVALENT	1
IN2BONES USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
INSTRATEK, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDSHAPE, INC
	SUBSTANTIALLY EQUIVALENT	1
MORTISE MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHOHELIX SURGICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPAEDIC IMPLANT COMPANY
	SUBSTANTIALLY EQUIVALENT	1
PANTHER ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1
SMITH AND NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGICRAFT LTD.
	SUBSTANTIALLY EQUIVALENT	1
TRIMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
VILEX LLC
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
XIROS LTD
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	321	321
Adverse Event Without Identified Device or Use Problem	182	182
Device-Device Incompatibility	43	43
Appropriate Term/Code Not Available	27	27
Detachment of Device or Device Component	26	26
Device Dislodged or Dislocated	26	26
Material Split, Cut or Torn	24	24
Migration	21	21
Patient Device Interaction Problem	20	20
Device Slipped	19	19
Difficult to Advance	18	18
Entrapment of Device	15	15
Fracture	13	13
Defective Device	13	13
Use of Device Problem	11	11
Device Operates Differently Than Expected	11	11
Insufficient Information	11	11
Material Separation	9	9
Physical Resistance/Sticking	9	9
Migration or Expulsion of Device	8	8
Material Twisted/Bent	7	7
Material Frayed	6	6
Detachment Of Device Component	6	6
Patient-Device Incompatibility	6	6
Difficult To Position	5	5
Improper or Incorrect Procedure or Method	5	5
Failure to Advance	5	5
Difficult to Remove	5	5
Material Fragmentation	4	4
Loosening of Implant Not Related to Bone-Ingrowth	4	4
Material Rupture	3	3
No Apparent Adverse Event	3	3
Positioning Problem	3	3
Material Integrity Problem	3	3
Expiration Date Error	3	3
Unintended Movement	3	3
Device Markings/Labelling Problem	3	3
Loose or Intermittent Connection	3	3
Expulsion	3	3
Fitting Problem	3	3
Unstable	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Activation Problem	2	2
Output Problem	2	2
Component Missing	2	2
Failure to Align	2	2
Mechanical Problem	2	2
Material Protrusion/Extrusion	2	2
Activation, Positioning or Separation Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	286	286
Insufficient Information	122	122
No Code Available	102	102
Pain	88	88
Failure of Implant	57	57
Unspecified Infection	44	44
No Known Impact Or Consequence To Patient	40	40
Non-union Bone Fracture	31	31
Foreign Body In Patient	31	31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	29	29
No Consequences Or Impact To Patient	21	21
Impaired Healing	16	16
Bone Fracture(s)	16	16
No Information	13	13
Device Embedded In Tissue or Plaque	11	11
Joint Dislocation	11	11
Injury	10	10
Necrosis	10	10
Hypersensitivity/Allergic reaction	9	9
Reaction	8	8
Discomfort	8	8
Swelling	8	8
Loss of Range of Motion	7	7
Osteolysis	6	6
Post Operative Wound Infection	5	5
Tissue Damage	5	5
Limited Mobility Of The Implanted Joint	4	4
Implant Pain	4	4
Bacterial Infection	4	4
Physical Asymmetry	4	4
Irritation	4	4
Fall	3	3
Inflammation	3	3
Foreign Body Reaction	3	3
Abscess	2	2
Limb Fracture	2	2
Anxiety	2	2
Swelling/ Edema	2	2
Wound Dehiscence	2	2
No Patient Involvement	2	2
Nerve Damage	2	2
Erythema	2	2
Arthralgia	2	2
Rash	2	2
Arthritis	2	2
Distress	2	2
Damage to Ligament(s)	2	2
Hematoma	2	2
Fatigue	2	2
Not Applicable	2	2