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
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	5923	5927
Adverse Event Without Identified Device or Use Problem	626	627
Device-Device Incompatibility	428	428
Migration	357	357
Device Dislodged or Dislocated	324	324
Detachment of Device or Device Component	305	305
Material Deformation	301	301
Crack	297	298
Patient Device Interaction Problem	189	189
Difficult to Advance	177	177
Premature Activation	115	115
Fracture	111	111
Device Damaged Prior to Use	98	98
Positioning Failure	96	96
Failure to Advance	90	90
Material Twisted/Bent	67	67
Physical Resistance/Sticking	65	65
Defective Device	64	64
Use of Device Problem	60	60
Mechanical Jam	55	55
Unintended Movement	49	49
Material Split, Cut or Torn	44	44
Appropriate Term/Code Not Available	42	42
Material Fragmentation	41	41
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
Loosening of Implant Not Related to Bone-Ingrowth	21	21
Fitting Problem	21	21
Difficult to Remove	18	18
Packaging Problem	17	17
Delivered as Unsterile Product	17	17
Material Separation	15	15
Separation Failure	12	12
Device Damaged by Another Device	12	12
Positioning Problem	11	11
Product Quality Problem	10	10
Flaked	10	10
Loose or Intermittent Connection	10	10
Output Problem	9	9
Manufacturing, Packaging or Shipping Problem	8	8
Component Missing	8	8
Migration or Expulsion of Device	8	8
Patient-Device Incompatibility	7	8
Device Markings/Labelling Problem	7	7
Material Protrusion/Extrusion	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	7465	7469
Insufficient Information	730	730
Unspecified Tissue Injury	382	382
Foreign Body In Patient	367	368
Unspecified Infection	213	213
Failure of Implant	196	196
Device Embedded In Tissue or Plaque	84	84
Perforation	84	84
Pain	83	84
Swelling/ Edema	44	45
Hypersensitivity/Allergic reaction	42	43
Rupture	41	41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	40	40
Nerve Damage	37	37
Joint Laxity	32	32
Foreign Body Reaction	31	31
Inflammation	21	21
Loss of Range of Motion	20	20
Impaired Healing	17	17
Damage to Ligament(s)	14	14
Joint Dislocation	14	14
Post Operative Wound Infection	12	12
Abscess	11	12
Discomfort	11	11
Fluid Discharge	10	10
Bacterial Infection	9	10
Muscle/Tendon Damage	9	9
Adhesion(s)	9	9
Synovitis	9	9
Sepsis	8	8
Implant Pain	8	8
Necrosis	7	7
Numbness	7	7
Osteolysis	7	7
Fatigue	6	6
Thrombosis/Thrombus	6	6
Rash	5	5
Local Reaction	5	5
Cyst(s)	5	5
Bone Fracture(s)	5	5
Purulent Discharge	4	4
Itching Sensation	4	4
Hemorrhage/Bleeding	4	4
Wound Dehiscence	4	4
Hematoma	4	4
Respiratory Failure	3	3
Scar Tissue	3	3
Laceration(s)	3	4
Fever	3	3
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	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	Jun-02-2023
4	Smith & Nephew, Inc.	II	Apr-29-2021