TPLC - Total Product Life Cycle

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Device	bone cement, posterior screw augmentation
Definition	The device is intended to augment the fixation of screws in a posterior spinal system construct.
Product Code	PML
Regulation Number	888.3027
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SÀRL
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC SOFAMOR DANEK USA, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK, USA INC.
	SUBSTANTIALLY EQUIVALENT	1
NEO MEDICAL SA
	SUBSTANTIALLY EQUIVALENT	2
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
SPINEART
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ULRICH MEDICAL USA
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	66	66
Adverse Event Without Identified Device or Use Problem	52	52
Loose or Intermittent Connection	23	23
Migration	17	17
Entrapment of Device	11	11
Device Slipped	10	10
Disconnection	7	7
Material Twisted/Bent	6	6
Device-Device Incompatibility	4	4
Detachment of Device or Device Component	4	4
No Apparent Adverse Event	4	4
Crack	3	3
Insufficient Information	3	3
Expiration Date Error	3	3
Device Dislodged or Dislocated	3	3
Leak/Splash	2	2
Compatibility Problem	2	2
Mechanical Problem	2	2
Torn Material	1	1
Difficult to Advance	1	1
Disassembly	1	1
Backflow	1	1
Improper Flow or Infusion	1	1
Material Deformation	1	1
Failure to Infuse	1	1
Appropriate Term/Code Not Available	1	1
Thickening of Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	44	44
No Clinical Signs, Symptoms or Conditions	41	41
No Consequences Or Impact To Patient	24	24
Failure of Implant	22	22
Insufficient Information	22	22
Spinal Column Injury	14	14
Foreign Body In Patient	14	14
Osteolysis	13	13
Not Applicable	12	12
Pain	11	11
Unspecified Infection	10	10
Nerve Damage	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Hypersensitivity/Allergic reaction	7	7
Post Operative Wound Infection	7	7
No Known Impact Or Consequence To Patient	7	7
Impaired Healing	6	6
Joint Laxity	5	5
Tissue Damage	4	4
Non-union Bone Fracture	3	3
Unspecified Tissue Injury	3	3
Bone Fracture(s)	2	2
Metal Related Pathology	1	1
Necrosis	1	1
Hematoma	1	1
Paralysis	1	1
Extravasation	1	1
Hemorrhage/Bleeding	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Icotec Ag	II	Jan-10-2024