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
	SUBSTANTIALLY EQUIVALENT	1
ACUITIVE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	4
AJU PHARM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	8
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	3
B-ONE ORTHO, CORP
	SUBSTANTIALLY EQUIVALENT	1
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
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	2
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
SURGICAL FUSION TECHNOLOGIES GMBH
	SUBSTANTIALLY EQUIVALENT	1
TEKNIMED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	4689	4689
Adverse Event Without Identified Device or Use Problem	688	688
Device-Device Incompatibility	475	475
Migration	296	296
Detachment of Device or Device Component	273	273
Material Deformation	259	259
Crack	246	246
Device Dislodged or Dislocated	244	244
Difficult to Advance	153	153
Premature Activation	121	121
Device Damaged Prior to Use	97	97
Fracture	82	82
Material Separation	70	70
Material Twisted/Bent	68	68
Mechanical Jam	59	59
Insufficient Information	58	58
Failure to Advance	57	57
Patient Device Interaction Problem	56	56
Positioning Failure	55	55
Defective Device	54	54
Physical Resistance/Sticking	50	50
Unintended Movement	47	47
Loose or Intermittent Connection	43	43
Migration or Expulsion of Device	43	43
Appropriate Term/Code Not Available	42	42
Entrapment of Device	41	41
Use of Device Problem	38	38
Material Split, Cut or Torn	37	37
Material Fragmentation	33	33
Difficult to Insert	25	25
Material Frayed	23	23
Device Contaminated During Manufacture or Shipping	20	20
Difficult to Remove	20	20
Delivered as Unsterile Product	17	17
Manufacturing, Packaging or Shipping Problem	17	17
Fitting Problem	16	16
Patient-Device Incompatibility	15	15
Packaging Problem	13	13
Positioning Problem	12	12
Output Problem	9	9
Loosening of Implant Not Related to Bone-Ingrowth	9	9
Unsealed Device Packaging	8	8
Product Quality Problem	7	7
Mechanical Problem	7	7
Device Slipped	6	6
Device Markings/Labelling Problem	6	6
Flaked	6	6
Unstable	6	6
Biocompatibility	6	6
Expulsion	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5613	5613
Insufficient Information	572	572
Unspecified Tissue Injury	403	403
No Consequences Or Impact To Patient	353	353
Foreign Body In Patient	336	336
Unspecified Infection	215	215
Failure of Implant	151	151
Not Applicable	100	100
Device Embedded In Tissue or Plaque	84	84
Pain	64	64
No Information	60	60
No Code Available	57	57
Perforation	55	55
No Known Impact Or Consequence To Patient	54	54
Injury	51	51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	42	42
Rupture	40	40
Tissue Damage	35	35
Swelling/ Edema	34	34
Nerve Damage	34	34
Hypersensitivity/Allergic reaction	32	32
Foreign Body Reaction	31	31
Inflammation	28	28
Joint Laxity	21	21
Impaired Healing	18	18
Loss of Range of Motion	16	16
No Patient Involvement	15	15
Post Operative Wound Infection	14	14
Damage to Ligament(s)	14	14
Fluid Discharge	12	12
Abscess	11	11
Hemorrhage/Bleeding	11	11
Synovitis	9	9
Adhesion(s)	8	8
Sepsis	8	8
Discomfort	8	8
Purulent Discharge	7	7
Cyst(s)	7	7
Muscle/Tendon Damage	7	7
Reaction	7	7
Rash	7	7
Joint Dislocation	6	6
Osteolysis	6	6
Swelling	6	6
Bone Fracture(s)	5	5
Local Reaction	5	5
Staphylococcus Aureus	5	5
Thrombosis/Thrombus	5	5
Hematoma	4	4
Implant Pain	4	4

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