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	8
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	5830	5832
Adverse Event Without Identified Device or Use Problem	606	607
Device-Device Incompatibility	428	428
Migration	377	377
Device Dislodged or Dislocated	352	352
Material Deformation	306	306
Crack	300	301
Detachment of Device or Device Component	287	287
Patient Device Interaction Problem	198	198
Difficult to Advance	191	191
Fracture	137	137
Premature Activation	117	117
Positioning Failure	109	109
Device Damaged Prior to Use	98	98
Failure to Advance	97	97
Physical Resistance/Sticking	64	64
Use of Device Problem	62	62
Defective Device	61	61
Material Twisted/Bent	59	59
Mechanical Jam	53	53
Unintended Movement	51	51
Material Split, Cut or Torn	35	35
Insufficient Device Problem Information	34	34
Material Fragmentation	34	34
Appropriate Device Problem Term/Code Not Available	33	33
Device Contaminated During Manufacture or Shipping	31	31
Damaged Thread	22	22
Loosening of Implant Not Related to Bone-Ingrowth	20	20
Difficult to Insert	18	18
Delivered as Unsterile Product	18	18
Packaging Problem	17	17
Material Frayed	16	16
Fitting Problem	16	16
Device Damaged by Another Device	12	12
Separation Failure	12	12
Product Quality Problem	10	10
Material Separation	9	9
Unstable	7	7
Component Missing	7	7
Migration or Expulsion of Device	7	7
Flaked	6	6
Expiration Date Error	6	6
Material Protrusion/Extrusion	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Contamination /Decontamination Problem	6	6
Biocompatibility	6	6
Expulsion	5	5
Device Markings/Labelling Problem	5	5
Device Damaged Prior to Receipt by User	5	5
Positioning Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8081	8085
Insufficient Information	754	754
Unspecified Tissue Injury	384	384
Foreign Body In Patient	379	380
Unspecified Infection	214	214
Failure of Implant	198	198
Perforation	94	94
Device Embedded In Tissue or Plaque	88	88
Pain	85	86
Swelling/ Edema	44	45
Rupture	43	43
Hypersensitivity/Allergic reaction	42	43
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	40	40
Nerve Damage	38	38
Joint Laxity	35	35
Foreign Body Reaction	32	32
Loss of Range of Motion	24	24
Inflammation	23	23
Impaired Healing	17	17
Damage to Ligament(s)	14	14
Joint Dislocation	14	14
Discomfort	12	12
Post Operative Wound Infection	12	12
Abscess	11	12
Muscle/Tendon Damage	11	11
Fluid Discharge	10	10
Adhesion(s)	9	9
Synovitis	9	9
Bacterial Infection	9	10
Arthropathy	9	9
Implant Pain	8	8
Sepsis	8	8
Numbness	7	7
Osteolysis	7	7
Necrosis	7	7
Thrombosis/Thrombus	6	6
Fatigue	6	6
Bone Fracture(s)	6	6
Itching Sensation	5	5
Cyst(s)	5	5
Local Reaction	5	5
Rash	5	5
Arthrofibrosis	4	4
Hematoma	4	4
Inadequate Osseointegration	4	4
Purulent Discharge	4	4
Hemorrhage/Blood Loss/Bleeding	4	4
Wound Dehiscence	4	4
Loss of fracture reduction	4	4
Laceration(s)	3	4

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