TPLC - Total Product Life Cycle

show TPLC since

Device	screw, fixation, bone, non-spinal, metallic
Product Code	NDJ
Regulation Number	888.3040
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	220	220
Loss of Osseointegration	131	131
Adverse Event Without Identified Device or Use Problem	77	77
Osseointegration Problem	24	24
Appropriate Term/Code Not Available	14	14
Malposition of Device	11	11
Metal Shedding Debris	11	11
Inadequacy of Device Shape and/or Size	5	5
Loose or Intermittent Connection	5	5
Loss of or Failure to Bond	5	5
Break	5	5
Migration or Expulsion of Device	3	3
Device Dislodged or Dislocated	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Difficult to Advance	1	1
Migration	1	1
Detachment Of Device Component	1	1
Component Falling	1	1
Corroded	1	1
Entrapment of Device	1	1
Fracture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	160	160
Pain	149	149
No Information	119	119
No Code Available	57	57
Discomfort	36	36
Foreign Body Reaction	27	27
Inadequate Osseointegration	22	22
Host-Tissue Reaction	21	21
Inflammation	19	19
Limited Mobility Of The Implanted Joint	15	15
Osteolysis	12	12
Pulmonary Embolism	12	12
Tissue Damage	12	12
Bone Fracture(s)	11	11
Cardiac Arrest	10	10
Infarction, Cerebral	9	9
Ambulation Difficulties	8	8
Hypersensitivity/Allergic reaction	6	6
Fall	6	6
Not Applicable	5	5
Cyst(s)	4	4
Loss of Range of Motion	4	4
Necrosis	4	4
Swelling	4	4
Weakness	3	3
Injury	3	3
Edema	3	3
Adhesion(s)	3	3
Erosion	3	3
Abscess	2	2
Synovitis	2	2
Scar Tissue	2	2
Deformity/ Disfigurement	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Sleep Dysfunction	1	1
Fibrosis	1	1
Sepsis	1	1
Nerve Damage	1	1
Joint Swelling	1	1
Toxicity	1	1
No Consequences Or Impact To Patient	1	1
Anxiety	1	1
Distress	1	1
Fatigue	1	1
Hematoma	1	1
Muscle Spasm(s)	1	1
Muscular Rigidity	1	1