TPLC - Total Product Life Cycle

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Device	fastener, fixation, biodegradable, soft tissue
Regulation Description	Single/multiple component metallic bone fixation appliances and accessories.
Product Code	MAI
Regulation Number	888.3030
Device Class	2

Premarket Reviews
Manufacturer	Decision
ACUITIVE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	4
AJU PHARM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	7
B-ONE ORTHO, CORP.
	SUBSTANTIALLY EQUIVALENT	1
BIOCOMPOSITES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
1. K240090 Argo Knotless GENESYS Anchor
2. K252946 BioBrace® Extra-Articular Ligament Augmentation Ki ...
DEPUY MITEK
	SUBSTANTIALLY EQUIVALENT	3
EMBODY, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
NANOFIBER SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	2
OSSIO , LTD.
	SUBSTANTIALLY EQUIVALENT	5
OSTEONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
PARCUS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SCIENCE & BIO MATERIALS (S.B.M.) SAS
	SUBSTANTIALLY EQUIVALENT	1
STRYKER ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	2
SURGICAL FUSION TECHNOLOGIES GMBH
	SUBSTANTIALLY EQUIVALENT	1
TEKNIMED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	5779	5783
Adverse Event Without Identified Device or Use Problem	624	625
Device-Device Incompatibility	428	428
Migration	352	352
Device Dislodged or Dislocated	318	318
Detachment of Device or Device Component	300	300
Material Deformation	295	295
Crack	292	293
Patient Device Interaction Problem	182	182
Difficult to Advance	176	176
Premature Activation	115	115
Fracture	107	107
Device Damaged Prior to Use	98	98
Failure to Advance	90	90
Positioning Failure	90	90
Physical Resistance/Sticking	64	64
Defective Device	64	64
Material Twisted/Bent	64	64
Use of Device Problem	60	60
Mechanical Jam	53	53
Unintended Movement	49	49
Material Split, Cut or Torn	44	44
Appropriate Term/Code Not Available	42	42
Material Fragmentation	39	39
Insufficient Information	36	36
Difficult to Insert	32	32
Device Contaminated During Manufacture or Shipping	27	27
Material Frayed	24	24
Entrapment of Device	24	24
Fitting Problem	21	21
Difficult to Remove	18	18
Loosening of Implant Not Related to Bone-Ingrowth	16	16
Delivered as Unsterile Product	16	16
Packaging Problem	16	16
Material Separation	15	15
Device Damaged by Another Device	12	12
Separation Failure	12	12
Positioning Problem	11	11
Product Quality Problem	10	10
Loose or Intermittent Connection	10	10
Output Problem	9	9
Manufacturing, Packaging or Shipping Problem	8	8
Migration or Expulsion of Device	8	8
Patient-Device Incompatibility	7	8
Component Missing	7	7
Device Markings/Labelling Problem	7	7
Material Protrusion/Extrusion	6	6
Flaked	6	6
Biocompatibility	6	6
Contamination /Decontamination Problem	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7294	7298
Insufficient Information	720	720
Unspecified Tissue Injury	381	381
Foreign Body In Patient	360	361
Unspecified Infection	213	213
Failure of Implant	195	195
Perforation	84	84
Device Embedded In Tissue or Plaque	84	84
Pain	75	76
Swelling/ Edema	43	44
Hypersensitivity/Allergic reaction	42	43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	40	40
Rupture	38	38
Nerve Damage	36	36
Joint Laxity	31	31
Foreign Body Reaction	29	29
Inflammation	21	21
Loss of Range of Motion	19	19
Impaired Healing	17	17
Joint Dislocation	14	14
Damage to Ligament(s)	14	14
Post Operative Wound Infection	12	12
Discomfort	11	11
Abscess	11	12
Fluid Discharge	10	10
Adhesion(s)	9	9
Bacterial Infection	9	10
Synovitis	9	9
Muscle/Tendon Damage	9	9
Sepsis	8	8
Implant Pain	8	8
Osteolysis	7	7
Numbness	7	7
Necrosis	7	7
Fatigue	6	6
Thrombosis/Thrombus	6	6
Bone Fracture(s)	5	5
Cyst(s)	5	5
Rash	5	5
Local Reaction	5	5
Itching Sensation	4	4
Purulent Discharge	4	4
Wound Dehiscence	4	4
Hematoma	4	4
Hemorrhage/Bleeding	4	4
Fever	3	3
Laceration(s)	3	4
Osteopenia/ Osteoporosis	3	3
Respiratory Failure	3	3
Scar Tissue	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Aju Pharm Co., Ltd.	II	Jan-26-2026
2	Arthrex, Inc.	II	Jul-21-2021
3	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	Jun-02-2023
4	Smith & Nephew, Inc.	II	Apr-29-2021