TPLC - Total Product Life Cycle

show TPLC since

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
	SUBSTANTIALLY EQUIVALENT	1
ACUITIVE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	4
AJU PHARM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	11
B-ONE ORTHO, CORP.
	SUBSTANTIALLY EQUIVALENT	1
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
DEPUY MITEK
	SUBSTANTIALLY EQUIVALENT	3
EMBODY, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
NANOFIBER SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	3
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
SMITH & NEPHEW, INC.
	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	5774	5778
Adverse Event Without Identified Device or Use Problem	704	705
Device-Device Incompatibility	479	479
Migration	344	344
Detachment of Device or Device Component	309	309
Device Dislodged or Dislocated	305	305
Crack	301	302
Material Deformation	289	289
Difficult to Advance	168	168
Premature Activation	121	121
Patient Device Interaction Problem	112	112
Fracture	104	104
Device Damaged Prior to Use	101	101
Failure to Advance	91	91
Positioning Failure	90	90
Material Twisted/Bent	82	82
Material Separation	71	71
Mechanical Jam	65	65
Defective Device	63	63
Physical Resistance/Sticking	62	62
Insufficient Information	62	62
Use of Device Problem	51	51
Unintended Movement	50	50
Appropriate Term/Code Not Available	47	47
Material Split, Cut or Torn	44	44
Material Fragmentation	44	44
Loose or Intermittent Connection	43	43
Migration or Expulsion of Device	43	43
Entrapment of Device	42	42
Difficult to Insert	30	30
Material Frayed	26	26
Device Contaminated During Manufacture or Shipping	25	25
Fitting Problem	21	21
Difficult to Remove	20	20
Delivered as Unsterile Product	19	19
Manufacturing, Packaging or Shipping Problem	18	18
Packaging Problem	16	16
Patient-Device Incompatibility	15	17
Device Damaged by Another Device	12	12
Positioning Problem	12	12
Separation Failure	11	11
Loosening of Implant Not Related to Bone-Ingrowth	10	10
Product Quality Problem	9	9
Output Problem	9	9
Unsealed Device Packaging	8	8
Mechanical Problem	7	7
Biocompatibility	6	6
Contamination /Decontamination Problem	6	6
Expiration Date Error	6	6
Device Slipped	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6905	6909
Insufficient Information	687	687
Unspecified Tissue Injury	407	407
Foreign Body In Patient	383	384
No Consequences Or Impact To Patient	353	353
Unspecified Infection	229	230
Failure of Implant	162	162
Not Applicable	100	100
Device Embedded In Tissue or Plaque	96	96
Perforation	78	78
Pain	75	76
No Information	60	60
No Code Available	57	57
No Known Impact Or Consequence To Patient	54	54
Injury	51	51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	42	42
Hypersensitivity/Allergic reaction	41	42
Rupture	40	40
Swelling/ Edema	38	39
Nerve Damage	37	37
Tissue Damage	35	35
Foreign Body Reaction	32	32
Inflammation	29	30
Joint Laxity	24	24
Impaired Healing	20	20
Loss of Range of Motion	17	17
No Patient Involvement	15	15
Post Operative Wound Infection	15	15
Damage to Ligament(s)	14	14
Fluid Discharge	12	12
Abscess	11	12
Hemorrhage/Bleeding	11	11
Adhesion(s)	9	9
Synovitis	9	9
Discomfort	9	9
Implant Pain	8	8
Purulent Discharge	8	8
Sepsis	8	8
Rash	8	8
Reaction	7	7
Cyst(s)	7	7
Necrosis	7	7
Muscle/Tendon Damage	7	7
Osteolysis	6	6
Swelling	6	6
Joint Dislocation	6	6
Bone Fracture(s)	5	5
Local Reaction	5	5
Staphylococcus Aureus	5	5
Bacterial Infection	5	6

Recalls
Manufacturer		Recall Class	Date Posted
1	Arthrex, Inc.	II	Jul-21-2021
2	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	Jun-02-2023
3	Smith & Nephew, Inc.	II	Apr-29-2021
4	Smith & Nephew, Inc.	II	Oct-21-2020