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	9
B-ONE ORTHO, CORP.
	SUBSTANTIALLY EQUIVALENT	1
BIOCOMPOSITES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
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	2
TEKNIMED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	6101	6103
Adverse Event Without Identified Device or Use Problem	616	617
Device-Device Incompatibility	433	433
Migration	402	402
Device Dislodged or Dislocated	372	372
Material Deformation	321	321
Crack	307	308
Detachment of Device or Device Component	292	292
Patient Device Interaction Problem	221	221
Difficult to Advance	200	200
Fracture	159	159
Premature Activation	118	118
Positioning Failure	111	111
Failure to Advance	102	102
Device Damaged Prior to Use	98	98
Physical Resistance/Sticking	67	67
Material Twisted/Bent	63	63
Use of Device Problem	63	63
Defective Device	62	62
Mechanical Jam	54	54
Unintended Movement	52	52
Material Split, Cut or Torn	36	36
Material Fragmentation	36	36
Insufficient Device Problem Information	34	34
Appropriate Device Problem Term/Code Not Available	33	33
Device Contaminated During Manufacture or Shipping	32	32
Damaged Thread	22	22
Loosening of Implant Not Related to Bone-Ingrowth	21	21
Delivered as Unsterile Product	18	18
Difficult to Insert	18	18
Packaging Problem	17	17
Fitting Problem	16	16
Material Frayed	16	16
Separation Failure	12	12
Device Damaged by Another Device	12	12
Device Damaged Prior to Receipt by User	10	10
Material Separation	10	10
Product Quality Problem	10	10
Migration or Expulsion of Device	7	7
Unstable	7	7
Component Missing	7	7
Flaked	6	6
Material Protrusion/Extrusion	6	6
Expiration Date Error	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Contamination /Decontamination Problem	6	6
Biocompatibility	6	6
Device Markings/Labelling Problem	5	5
Expulsion	5	5
Component Misassembled	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8426	8430
Insufficient Information	768	768
Foreign Body In Patient	394	395
Unspecified Tissue Injury	385	385
Unspecified Infection	216	216
Failure of Implant	206	206
Device Embedded In Tissue or Plaque	95	95
Perforation	95	95
Pain	93	94
Swelling/ Edema	54	55
Hypersensitivity/Allergic reaction	43	44
Rupture	43	43
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	42	42
Nerve Damage	40	40
Joint Laxity	35	35
Foreign Body Reaction	32	32
Inflammation	32	32
Loss of Range of Motion	24	24
Impaired Healing	17	17
Bacterial Infection	16	17
Damage to Ligament(s)	14	14
Joint Dislocation	14	14
Discomfort	12	12
Post Operative Wound Infection	12	12
Muscle/Tendon Damage	11	11
Abscess	11	12
Fluid Discharge	10	10
Adhesion(s)	9	9
Synovitis	9	9
Implant Pain	9	9
Arthropathy	9	9
Sepsis	8	8
Necrosis	7	7
Thrombosis/Thrombus	7	7
Osteolysis	7	7
Numbness	7	7
Bone Fracture(s)	6	6
Fatigue	6	6
Cyst(s)	5	5
Itching Sensation	5	5
Local Reaction	5	5
Rash	5	5
Hematoma	4	4
Purulent Discharge	4	4
Inadequate Osseointegration	4	4
Arthrofibrosis	4	4
Loss of fracture reduction	4	4
Wound Dehiscence	4	4
Hemorrhage/Blood Loss/Bleeding	4	4
Osteopenia/ Osteoporosis	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	ConMed Corporation	II	Aug-26-2026
4	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	Jun-02-2023
5	Smith & Nephew, Inc.	II	Apr-29-2021