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
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	2
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
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	1
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	367	367
Adverse Event Without Identified Device or Use Problem	295	299
Detachment of Device or Device Component	127	127
Fracture	79	79
Migration	36	39
Device-Device Incompatibility	32	32
Device Dislodged or Dislocated	32	32
Manufacturing, Packaging or Shipping Problem	30	30
Physical Resistance/Sticking	25	25
Difficult to Advance	22	22
Crack	20	20
Material Split, Cut or Torn	19	19
Material Separation	17	17
Appropriate Term/Code Not Available	17	17
Loosening of Implant Not Related to Bone-Ingrowth	17	17
Migration or Expulsion of Device	16	16
Patient Device Interaction Problem	13	13
Insufficient Information	13	13
Material Frayed	9	9
Material Deformation	9	9
Entrapment of Device	9	9
Material Twisted/Bent	8	8
No Apparent Adverse Event	6	6
Failure to Advance	6	6
Material Fragmentation	6	6
Difficult to Remove	5	5
Unintended Movement	5	5
Device Damaged by Another Device	4	4
Inaccurate Information	4	4
Patient-Device Incompatibility	4	4
Activation Problem	4	4
Loose or Intermittent Connection	4	4
Mechanical Jam	4	4
Mechanical Problem	4	4
Material Integrity Problem	3	3
Defective Component	3	3
Connection Problem	3	3
Corroded	3	3
Delivered as Unsterile Product	3	3
Device Contaminated During Manufacture or Shipping	3	3
Packaging Problem	3	3
Therapeutic or Diagnostic Output Failure	2	2
Firing Problem	2	2
Failure to Form Staple	2	2
Flaked	2	2
Device Damaged Prior to Use	2	2
Failure to Eject	2	2
Positioning Failure	2	2
Component Missing	2	2
Failure to Align	2	2

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	104	104
Pain	95	95
Non-union Bone Fracture	75	75
No Code Available	59	59
Insufficient Information	56	56
Injury	55	55
Tissue Damage	48	48
Failure of Implant	47	47
Not Applicable	45	45
No Known Impact Or Consequence To Patient	41	41
Foreign Body In Patient	35	35
Unspecified Infection	30	30
Unspecified Tissue Injury	26	26
Bone Fracture(s)	23	23
Loss of Range of Motion	21	24
No Patient Involvement	19	19
Post Operative Wound Infection	19	19
Perforation	15	15
Impaired Healing	14	14
Hypersensitivity/Allergic reaction	13	13
No Information	13	13
Implant Pain	12	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Discomfort	11	11
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
Joint Dislocation	4	4
Cyst(s)	4	4
Hematoma	4	4
Inflammation	4	4
Rupture	4	4
Arthritis	3	3
Skin Infection	3	3
Synovitis	3	3
Cellulitis	3	3
Osteolysis	3	3
Erosion	2	2
Bacterial Infection	2	2
Physical Asymmetry	2	2
Ulcer	2	2
Muscle/Tendon Damage	2	2
Stroke/CVA	2	2
Unspecified Musculoskeletal problem	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Mar-18-2022
2	Merete Medical GmbH	II	Feb-17-2022
3	Stryker GmbH	II	Nov-16-2020
4	Synthes (USA) Products LLC	II	Oct-18-2022
5	Synthes (USA) Products LLC	II	Oct-06-2022
6	Wright Medical Technology, Inc.	II	Mar-31-2022