TPLC - Total Product Life Cycle

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Device	posterior ratcheting rod system
Definition	Stabilization or correction of adolescent idiopathic scoliosis without the use of fusion.
Product Code	QGP
Device Class	Not Classified

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	57	57
Break	54	54
No Apparent Adverse Event	53	53
Fracture	38	38
Unintended Movement	34	34
Migration	19	19
Noise, Audible	17	17
Appropriate Term/Code Not Available	16	16
Improper or Incorrect Procedure or Method	14	14
Off-Label Use	7	7
Patient-Device Incompatibility	6	6
Insufficient Information	6	6
Loosening of Implant Not Related to Bone-Ingrowth	5	5
Device Dislodged or Dislocated	5	5
Failure to Align	3	3
Mechanical Problem	2	2
Detachment of Device or Device Component	2	2
Biocompatibility	2	2
Overcorrection	1	1
Collapse	1	1
Degraded	1	1
Use of Device Problem	1	1
Inaccurate Information	1	1
Mechanical Jam	1	1
Loss of Osseointegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	119	119
Failure of Implant	72	72
Pain	54	54
Implant Pain	20	20
Physical Asymmetry	19	19
Insufficient Information	17	17
Unspecified Infection	8	8
Discomfort	8	8
Post Operative Wound Infection	5	5
Bacterial Infection	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Wound Dehiscence	3	3
Unspecified Tissue Injury	2	2
Metal Related Pathology	1	1
Paresthesia	1	1
Osteolysis	1	1
Cerebrospinal Fluid Leakage	1	1
Fistula	1	1