TPLC - Total Product Life Cycle

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Device	intervertebral body graft containment device
Regulation Description	Intervertebral body graft containment device.
Definition	An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.
Product Code	OQB
Regulation Number	888.3085
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	9	9
Insufficient Information	5	5
Expulsion	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Improper or Incorrect Procedure or Method	2	2
Malposition of Device	1	1
Unintended Movement	1	1
Labelling, Instructions for Use or Training Problem	1	1
Detachment of Device or Device Component	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	9	9
Pain	7	7
No Clinical Signs, Symptoms or Conditions	6	6
Failure of Implant	5	5
Implant Pain	2	2
Foreign Body In Patient	2	2
Abdominal Pain	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Unspecified Nervous System Problem	1	1
Burning Sensation	1	1
Nerve Damage	1	1
Perforation of Vessels	1	1
Unspecified Vascular Problem	1	1