TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	1
CROSSROADS EXTEMITY SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
CROSSROADS EXTREMITY SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	2
EXOTOE LLC
	SUBSTANTIALLY EQUIVALENT	1
F & A FOUNDATION LLC D.B.A. REIGN MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
FUSION ORTHOPEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDARTIS AG
	SUBSTANTIALLY EQUIVALENT	1
MEDARTIS INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	2
MEDSHAPE, INC.
	SUBSTANTIALLY EQUIVALENT	3
NEOSTEO
	SUBSTANTIALLY EQUIVALENT	1
NEXTREMITY SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NOVASTEP
	SUBSTANTIALLY EQUIVALENT	1
NVISION BIOMEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHO SOLUTIONS UK LTD.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOVESTMENTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28 INC
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28, INC.
	SUBSTANTIALLY EQUIVALENT	1
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	1
RMR ORTHO, LLC
	SUBSTANTIALLY EQUIVALENT	1
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES (USA) PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	2
TREACE MEDICAL CONCEPTS
	SUBSTANTIALLY EQUIVALENT	3
TRIMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
TYBER MEDICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	1
VILEX, LLC
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	486	486
Adverse Event Without Identified Device or Use Problem	308	312
Detachment of Device or Device Component	134	134
Fracture	85	85
Migration	41	44
Material Frayed	37	37
Device-Device Incompatibility	34	34
Device Dislodged or Dislocated	33	33
Manufacturing, Packaging or Shipping Problem	30	30
Physical Resistance/Sticking	25	25
Material Split, Cut or Torn	23	23
Migration or Expulsion of Device	22	22
Difficult to Advance	22	22
Crack	22	22
Appropriate Term/Code Not Available	22	22
Loosening of Implant Not Related to Bone-Ingrowth	17	17
Material Separation	17	17
Insufficient Information	16	16
Patient Device Interaction Problem	13	13
Material Deformation	11	11
Entrapment of Device	9	9
Device Operates Differently Than Expected	8	8
Material Fragmentation	8	8
Material Twisted/Bent	8	8
Failure to Advance	7	7
Unintended Movement	6	6
No Apparent Adverse Event	6	6
Device Contaminated During Manufacture or Shipping	6	6
Mechanical Jam	6	6
Activation, Positioning or Separation Problem	6	6
Patient-Device Incompatibility	5	5
Connection Problem	5	5
Mechanical Problem	5	5
Difficult to Remove	5	5
Component Falling	5	5
Positioning Failure	5	5
Activation Problem	4	4
Inaccurate Information	4	4
Loose or Intermittent Connection	4	4
Packaging Problem	4	4
Device Damaged by Another Device	4	4
Failure to Form Staple	3	3
Corroded	3	3
Delivered as Unsterile Product	3	3
Detachment Of Device Component	3	3
Component Missing	3	3
Device Slipped	3	3
Material Integrity Problem	3	3
Defective Component	3	3
Separation Failure	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	496	496
No Consequences Or Impact To Patient	218	218
No Known Impact Or Consequence To Patient	110	110
Pain	104	104
Non-union Bone Fracture	82	82
No Code Available	73	73
Injury	60	60
Insufficient Information	56	56
Tissue Damage	53	53
Failure of Implant	52	52
Not Applicable	51	51
Foreign Body In Patient	41	41
Unspecified Infection	36	36
Unspecified Tissue Injury	26	26
Loss of Range of Motion	25	28
Bone Fracture(s)	24	24
No Patient Involvement	22	22
Post Operative Wound Infection	19	19
Impaired Healing	17	17
No Information	16	16
Hypersensitivity/Allergic reaction	15	15
Perforation	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Discomfort	12	12
Implant Pain	12	16
Skin Inflammation/ Irritation	10	10
Wound Dehiscence	8	8
Malunion of Bone	6	6
Device Embedded In Tissue or Plaque	5	5
Swelling/ Edema	5	5
Foreign Body Reaction	5	5
Abscess	4	4
Fall	4	4
Rupture	4	4
Inflammation	4	4
Hematoma	4	4
Joint Dislocation	4	4
Cyst(s)	4	4
Cellulitis	3	3
Arthritis	3	3
Weakness	3	3
Synovitis	3	3
Skin Infection	3	3
Nerve Damage	3	3
Swelling	3	3
Osteolysis	3	3
Erosion	2	2
Bacterial Infection	2	2
Physical Asymmetry	2	2
Ulcer	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Mar-18-2022
2	In2bones USA, LLC	II	Dec-22-2018
3	Merete Medical GmbH	II	Feb-17-2022
4	Paragon 28, Inc.	II	Jun-20-2018
5	Stryker GmbH	II	Nov-16-2020
6	Synthes (USA) Products LLC	II	Oct-18-2022
7	Synthes (USA) Products LLC	II	Oct-06-2022
8	TriMed Inc.	II	Jun-20-2018
9	Wright Medical Technology, Inc.	II	Mar-31-2022