TPLC - Total Product Life Cycle

show TPLC since

Device	shoulder spacer for massive irreparable rotator cuff tear, resorbable, inflatable, non-fixed
Regulation Description	Resorbable shoulder spacer.
Definition	A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears.
Product Code	QPQ
Regulation Number	888.3630
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient Device Interaction Problem	17	17
Device Dislodged or Dislocated	9	9
Patient-Device Incompatibility	6	6
Material Fragmentation	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Device Appears to Trigger Rejection	4	4
Material Rupture	3	3
Insufficient Information	2	2
Leak/Splash	1	1
Filling Problem	1	1
Material Puncture/Hole	1	1
Expiration Date Error	1	1
Component Missing	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	23	23
Pain	12	12
Unspecified Infection	9	9
Swelling/ Edema	6	6
Implant Pain	4	4
Synovitis	4	4
Inflammation	3	3
Erythema	3	3
Insufficient Information	3	3
Inadequate Pain Relief	2	2
Foreign Body In Patient	1	1
Fibrosis	1	1
Unspecified Nervous System Problem	1	1
Osteomyelitis	1	1
Skin Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Bacterial Infection	1	1
Fall	1	1
Failure of Implant	1	1
Subclinical Infection	1	1
Sepsis	1	1