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	152	152
Adverse Event Without Identified Device or Use Problem	72	72
Fracture	66	66
Physical Resistance/Sticking	44	44
Patient Device Interaction Problem	41	41
Mechanical Jam	23	23
Entrapment of Device	10	10
Nonstandard Device	10	10
Manufacturing, Packaging or Shipping Problem	9	9
Material Twisted/Bent	9	9
Difficult to Advance	7	7
Unintended Movement	7	7
Migration	5	5
Signal Artifact/Noise	5	5
Patient-Device Incompatibility	4	4
Naturally Worn	4	4
Detachment of Device or Device Component	3	3
Device Dislodged or Dislocated	3	3
Crack	3	3
Off-Label Use	3	3
Migration or Expulsion of Device	2	2
Improper or Incorrect Procedure or Method	2	2
Difficult or Delayed Activation	2	2
Failure to Fire	2	2
Device-Device Incompatibility	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Activation Failure	2	2
Firing Problem	2	2
Premature Separation	1	1
Noise, Audible	1	1
No Apparent Adverse Event	1	1
Failure to Eject	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Deformation	1	1
Material Integrity Problem	1	1
Malposition of Device	1	1
Defective Device	1	1
Component Missing	1	1
Failure to Align	1	1
Misassembled	1	1
Device Slipped	1	1
Use of Device Problem	1	1
Difficult or Delayed Positioning	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	201	201
Foreign Body In Patient	49	49
No Consequences Or Impact To Patient	48	48
No Information	36	36
Insufficient Information	31	31
Unspecified Infection	23	23
No Code Available	21	21
No Known Impact Or Consequence To Patient	16	16
Non-union Bone Fracture	16	16
Discomfort	15	15
Pain	10	10
Failure of Implant	10	10
Hypersensitivity/Allergic reaction	8	8
Unspecified Musculoskeletal problem	8	8
Nerve Damage	8	8
Device Embedded In Tissue or Plaque	4	4
Loss of consciousness	4	4
Fatigue	4	4
No Patient Involvement	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Post Operative Wound Infection	2	2
Sleep Dysfunction	2	2
Physical Asymmetry	2	2
Swelling/ Edema	2	2
Difficulty Chewing	2	2
Injury	2	2
Impaired Healing	1	1
Limited Mobility Of The Implanted Joint	1	1
Decreased Sensitivity	1	1
Fluid Discharge	1	1
Bone Fracture(s)	1	1
Increased Sensitivity	1	1
Inflammation	1	1