TPLC - Total Product Life Cycle

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Device	screw, fixation, intraosseous
Product Code	DZL
Regulation Number	872.4880
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	157	157
Fracture	70	70
Adverse Event Without Identified Device or Use Problem	68	68
Physical Resistance/Sticking	43	43
Patient Device Interaction Problem	41	41
Mechanical Jam	23	23
Entrapment of Device	9	9
Unintended Movement	8	8
Material Twisted/Bent	7	7
Difficult to Advance	6	6
Signal Artifact/Noise	5	5
Manufacturing, Packaging or Shipping Problem	4	4
Naturally Worn	4	4
Detachment of Device or Device Component	4	4
Migration or Expulsion of Device	3	3
Patient-Device Incompatibility	3	3
Device Dislodged or Dislocated	3	3
Off-Label Use	3	3
Migration	3	3
Firing Problem	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Activation Failure	2	2
Difficult to Remove	2	2
Material Rupture	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Crack	2	2
Difficult or Delayed Activation	2	2
Device-Device Incompatibility	2	2
Failure to Fire	2	2
Malposition of Device	1	1
Defective Device	1	1
Misassembled	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Deformation	1	1
Material Integrity Problem	1	1
Difficult or Delayed Positioning	1	1
Material Disintegration	1	1
Material Fragmentation	1	1
Component Missing	1	1
Failure to Align	1	1
Device Slipped	1	1
Noise, Audible	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Failure to Eject	1	1
Premature Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	150	150
No Consequences Or Impact To Patient	70	70
Foreign Body In Patient	51	51
No Information	42	42
Insufficient Information	27	27
No Code Available	25	25
Unspecified Infection	24	24
No Known Impact Or Consequence To Patient	20	20
Non-union Bone Fracture	16	16
Discomfort	15	15
Pain	11	11
Device Embedded In Tissue or Plaque	11	11
Unspecified Musculoskeletal problem	8	8
Nerve Damage	8	8
Hypersensitivity/Allergic reaction	7	7
Failure of Implant	6	6
Fatigue	4	4
Injury	4	4
Loss of consciousness	4	4
No Patient Involvement	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Physical Asymmetry	2	2
Swelling/ Edema	2	2
Difficulty Chewing	2	2
Post Operative Wound Infection	2	2
Sleep Dysfunction	2	2
Impaired Healing	2	2
Loss of Range of Motion	2	2
Ossification	2	2
Inflammation	1	1
Bone Fracture(s)	1	1
Increased Sensitivity	1	1
Tissue Damage	1	1
Limited Mobility Of The Implanted Joint	1	1
Decreased Sensitivity	1	1
Fluid Discharge	1	1