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
NEOSS LIMITED
	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	221	221
Fracture	77	78
Adverse Event Without Identified Device or Use Problem	68	68
Physical Resistance/Sticking	49	49
Patient Device Interaction Problem	42	42
Entrapment of Device	28	28
Mechanical Jam	23	23
Material Twisted/Bent	17	17
Manufacturing, Packaging or Shipping Problem	14	14
Nonstandard Device	10	10
Difficult to Advance	8	8
Crack	7	7
Unintended Movement	7	7
Signal Artifact/Noise	5	5
Migration	5	5
Off-Label Use	3	3
Material Deformation	3	3
Detachment of Device or Device Component	3	3
Device Dislodged or Dislocated	3	3
Migration or Expulsion of Device	2	2
Patient-Device Incompatibility	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Difficult or Delayed Activation	2	2
Device Damaged by Another Device	2	2
Failure to Fire	2	2
Activation Failure	2	2
Improper or Incorrect Procedure or Method	2	2
Device Slipped	1	1
Device Contaminated During Manufacture or Shipping	1	1
Malposition of Device	1	1
Defective Device	1	1
Material Integrity Problem	1	1
Failure to Align	1	1
Failure to Cut	1	1
Misassembled	1	1
No Apparent Adverse Event	1	1
Component Misassembled	1	1
Premature Separation	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	309	309
Foreign Body In Patient	73	74
Insufficient Information	45	45
No Information	34	34
No Consequences Or Impact To Patient	29	29
Unspecified Infection	18	18
Non-union Bone Fracture	16	16
Discomfort	15	15
Failure of Implant	14	14
No Code Available	10	10
Nerve Damage	9	9
Hypersensitivity/Allergic reaction	8	8
Unspecified Musculoskeletal problem	8	8
Pain	8	8
No Known Impact Or Consequence To Patient	7	7
Fatigue	4	4
Loss of consciousness	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Physical Asymmetry	3	3
Post Operative Wound Infection	2	2
Injury	2	2
Swelling/ Edema	2	2
Unspecified Tissue Injury	2	2
Impaired Healing	1	1
Decreased Sensitivity	1	1
Limited Mobility Of The Implanted Joint	1	1
Bone Fracture(s)	1	1
Inflammation	1	1
No Patient Involvement	1	1
Fluid Discharge	1	1
Extravasation	1	1
Increased Sensitivity	1	1
Device Embedded In Tissue or Plaque	1	1
Fistula	1	1