TPLC - Total Product Life Cycle

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Device	reherniation reduction device
Definition	The device is intended to reduce the incidence of reherniation, and reoperation following primary limited lumbar discectomy procedures (excision of herniated intervertebral disc).
Product Code	QES
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
0	0	1	2	2	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	44	44
Failure to Seal	24	24
Migration	13	13
Improper or Incorrect Procedure or Method	11	11
Device Dislodged or Dislocated	9	9
Fracture	8	8
Malposition of Device	5	5
Insufficient Information	4	4
Device Appears to Trigger Rejection	3	3
Failure to Advance	3	3
Difficult to Advance	2	2
Material Twisted/Bent	2	2
Unintended Movement	2	2
Difficult to Insert	1	1
Off-Label Use	1	1
Deformation Due to Compressive Stress	1	1
Detachment of Device or Device Component	1	1
Naturally Worn	1	1
Material Split, Cut or Torn	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hernia	44	44
Vertebral Fracture	18	18
Pain	15	15
No Clinical Signs, Symptoms or Conditions	9	9
Unspecified Infection	7	7
Insufficient Information	6	6
Nerve Damage	4	4
Hematoma	3	3
Numbness	3	3
Implant Pain	2	2
Post Operative Wound Infection	2	2
Osteolysis	2	2
Scar Tissue	2	2
Abscess	2	2
Joint Laxity	2	2
Bacterial Infection	2	2
Emotional Changes	1	1
Foreign Body Reaction	1	1
Ossification	1	1
Foreign Body In Patient	1	1
Seroma	1	1
Fall	1	1
Intervertebral Disc Compression or Protrusion	1	1