TPLC - Total Product Life Cycle

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Device	shoulder spacer for massive irreparable rotator cuff tear, resorbable, inflatable, non-fixed
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	11	11
Patient-Device Incompatibility	6	6
Device Dislodged or Dislocated	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Insufficient Information	2	2
Device Appears to Trigger Rejection	2	2
Material Rupture	2	2
Component Missing	1	1
Expiration Date Error	1	1
Appropriate Term/Code Not Available	1	1
Filling Problem	1	1
Material Puncture/Hole	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16	16
Unspecified Infection	6	6
Pain	6	6
Swelling/ Edema	5	5
Implant Pain	4	4
Synovitis	4	4
Erythema	3	3
Insufficient Information	3	3
Inadequate Pain Relief	2	2
Inflammation	2	2
Bacterial Infection	1	1
Subclinical Infection	1	1
Sepsis	1	1
Osteomyelitis	1	1
Skin Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1