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	230	230
Fracture	66	67
Adverse Event Without Identified Device or Use Problem	55	55
Patient Device Interaction Problem	42	42
Physical Resistance/Sticking	34	34
Entrapment of Device	29	29
Material Twisted/Bent	19	19
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
Off-Label Use	3	3
Detachment of Device or Device Component	3	3
Difficult to Advance	3	3
Material Deformation	3	3
Device Slipped	2	2
Migration or Expulsion of Device	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
No Apparent Adverse Event	2	2
Device Dislodged or Dislocated	2	2
Device Damaged by Another Device	2	2
Improper or Incorrect Procedure or Method	2	2
Device Contaminated During Manufacture or Shipping	1	1
Material Integrity Problem	1	1
Device-Device Incompatibility	1	1
Unintended Movement	1	1
Patient-Device Incompatibility	1	1
Insufficient Device Problem Information	1	1
Malposition of Device	1	1
Failure to Fire	1	1
Defective Device	1	1
Component Misassembled	1	1
Failure to Cut	1	1
Failure to Align	1	1
Misassembled	1	1
Loss of Osseointegration	1	1
Device Appears to Trigger Rejection	1	1
Difficult to Remove	1	1
Premature Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	332	332
Foreign Body In Patient	74	75
Insufficient Information	46	46
Discomfort	16	16
Nonunion/Delayed-union Bone Fracture	15	15
Failure of Implant	14	14
Nerve Damage	9	9
Hypersensitivity/Allergic reaction	9	9
Unspecified Musculoskeletal problem	8	8
Pain	8	8
Unspecified Infection	8	8
No Information	7	7
Fatigue	4	4
Loss of consciousness	4	4
No Consequences Or Impact To Patient	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3
Unspecified Tissue Injury	2	2
Physical Asymmetry	2	2
Swelling/ Edema	2	2
Fistula	2	2
Fluid Discharge	2	2
Impaired Healing	1	1
Inflammation	1	1
Extravasation	1	1
Post Operative Wound Infection	1	1