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	2
KLS-MARTIN L.P.
	SUBSTANTIALLY EQUIVALENT	1
NEOSS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
PROIMTECH SAGLIK URUNLERI ANONIM SIRKETI
	SUBSTANTIALLY EQUIVALENT	1
STRYKER LEIBINGER GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	186	186
Fracture	69	69
Adverse Event Without Identified Device or Use Problem	65	65
Physical Resistance/Sticking	47	47
Patient Device Interaction Problem	41	41
Entrapment of Device	23	23
Mechanical Jam	23	23
Material Twisted/Bent	15	15
Manufacturing, Packaging or Shipping Problem	10	10
Nonstandard Device	10	10
Difficult to Advance	8	8
Unintended Movement	7	7
Signal Artifact/Noise	5	5
Crack	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
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	264	264
Foreign Body In Patient	66	66
Insufficient Information	42	42
No Information	34	34
No Consequences Or Impact To Patient	29	29
Unspecified Infection	17	17
Non-union Bone Fracture	16	16
Discomfort	15	15
Failure of Implant	12	12
No Code Available	10	10
Hypersensitivity/Allergic reaction	8	8
Unspecified Musculoskeletal problem	8	8
Nerve Damage	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
Post Operative Wound Infection	2	2
Injury	2	2
Swelling/ Edema	2	2
Physical Asymmetry	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
Increased Sensitivity	1	1
Device Embedded In Tissue or Plaque	1	1