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
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	4
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	5618	5622
Adverse Event Without Identified Device or Use Problem	587	588
Device-Device Incompatibility	428	428
Migration	348	348
Device Dislodged or Dislocated	305	305
Detachment of Device or Device Component	297	297
Crack	289	290
Material Deformation	287	287
Difficult to Advance	169	169
Patient Device Interaction Problem	125	125
Premature Activation	114	114
Device Damaged Prior to Use	98	98
Fracture	97	97
Positioning Failure	87	87
Failure to Advance	87	87
Defective Device	64	64
Physical Resistance/Sticking	64	64
Material Twisted/Bent	62	62
Use of Device Problem	55	55
Mechanical Jam	53	53
Unintended Movement	48	48
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
Entrapment of Device	24	24
Material Frayed	24	24
Fitting Problem	21	21
Difficult to Remove	18	18
Delivered as Unsterile Product	16	16
Packaging Problem	16	16
Loosening of Implant Not Related to Bone-Ingrowth	15	15
Material Separation	15	15
Device Damaged by Another Device	12	12
Separation Failure	12	12
Positioning Problem	11	11
Loose or Intermittent Connection	10	10
Product Quality Problem	10	10
Output Problem	9	9
Manufacturing, Packaging or Shipping Problem	8	8
Migration or Expulsion of Device	8	8
Component Missing	7	7
Contamination /Decontamination Problem	6	6
Expiration Date Error	6	6
Flaked	6	6
Patient-Device Incompatibility	6	7
Biocompatibility	6	6
Material Protrusion/Extrusion	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7096	7100
Insufficient Information	704	704
Unspecified Tissue Injury	372	372
Foreign Body In Patient	352	353
Unspecified Infection	201	201
Failure of Implant	162	162
Device Embedded In Tissue or Plaque	82	82
Perforation	81	81
Pain	64	65
Hypersensitivity/Allergic reaction	41	42
Swelling/ Edema	41	42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	40	40
Nerve Damage	36	36
Rupture	35	35
Foreign Body Reaction	28	28
Joint Laxity	24	24
Inflammation	21	21
Loss of Range of Motion	15	15
Damage to Ligament(s)	14	14
Impaired Healing	14	14
Post Operative Wound Infection	12	12
Abscess	11	12
Fluid Discharge	10	10
Joint Dislocation	9	9
Muscle/Tendon Damage	9	9
Synovitis	9	9
Discomfort	9	9
Sepsis	8	8
Adhesion(s)	8	8
Implant Pain	8	8
Necrosis	7	7
Osteolysis	6	6
Thrombosis/Thrombus	6	6
Numbness	5	5
Local Reaction	5	5
Bacterial Infection	4	5
Hemorrhage/Bleeding	4	4
Rash	4	4
Purulent Discharge	4	4
Itching Sensation	4	4
Bone Fracture(s)	4	4
Cyst(s)	4	4
Hematoma	4	4
Osteopenia/ Osteoporosis	3	3
Laceration(s)	3	4
Scar Tissue	3	3
Respiratory Failure	3	3
Fever	2	2
Osteomyelitis	2	2
Localized Skin Lesion	2	2

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