TPLC - Total Product Life Cycle

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Device	screw, fixation, intraosseous
Regulation Description	Intraosseous fixation screw or wire.
Product Code	DZL
Regulation Number	872.4880
Device Class	2

Premarket Reviews
Manufacturer	Decision
DENTIS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HAGER& MEISINGER GMBH
	SUBSTANTIALLY EQUIVALENT	3
KLS-MARTIN L.P.
	SUBSTANTIALLY EQUIVALENT	1
OSSTEM IMPLANT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PROIMTECH SAGLIK URUNLERI ANONIM SIRKETI
	SUBSTANTIALLY EQUIVALENT	1
STRYKER LEIBINGER GMBH & CO KG
	SUBSTANTIALLY EQUIVALENT	1
USTOMED INSTRUMENTE ULRICH STORZ GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	224	224
Fracture	66	67
Adverse Event Without Identified Device or Use Problem	53	53
Patient Device Interaction Problem	42	42
Physical Resistance/Sticking	34	34
Entrapment of Device	29	29
Material Twisted/Bent	18	18
Mechanical Jam	12	12
Manufacturing, Packaging or Shipping Problem	11	11
Nonstandard Device	10	10
Crack	8	8
Signal Artifact/Noise	5	5
Migration	5	5
Material Deformation	3	3
Off-Label Use	3	3
Detachment of Device or Device Component	3	3
Difficult to Advance	3	3
Device Dislodged or Dislocated	3	3
Device Damaged by Another Device	2	2
Improper or Incorrect Procedure or Method	2	2
Migration or Expulsion of Device	2	2
No Apparent Adverse Event	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Component Misassembled	1	1
Premature Separation	1	1
Insufficient Information	1	1
Unintended Movement	1	1
Material Integrity Problem	1	1
Misassembled	1	1
Device Slipped	1	1
Failure to Align	1	1
Failure to Cut	1	1
Defective Device	1	1
Failure to Fire	1	1
Malposition of Device	1	1
Patient-Device Incompatibility	1	1
Device-Device Incompatibility	1	1
Device Contaminated During Manufacture or Shipping	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	323	323
Foreign Body In Patient	74	75
Insufficient Information	45	45
Discomfort	16	16
Non-union Bone Fracture	15	15
Failure of Implant	14	14
Nerve Damage	9	9
Hypersensitivity/Allergic reaction	8	8
Unspecified Musculoskeletal problem	8	8
No Information	7	7
Pain	7	7
Unspecified Infection	6	6
Fatigue	4	4
Loss of consciousness	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Consequences Or Impact To Patient	3	3
Unspecified Tissue Injury	2	2
Physical Asymmetry	2	2
Impaired Healing	1	1
Inflammation	1	1
Post Operative Wound Infection	1	1
Fluid Discharge	1	1
Extravasation	1	1
Swelling/ Edema	1	1
Fistula	1	1