TPLC - Total Product Life Cycle

show TPLC since

Premarket Reviews
Manufacturer	Decision
DAEHAN MEDICAL SYSTEMS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KIRWAN SURGICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEUROINVENT INC.
	SUBSTANTIALLY EQUIVALENT	2
PERSYST DEVELOPMENT CORP.
	SUBSTANTIALLY EQUIVALENT	1
RHYTHMLINK INTERNATIONAL, LLC
	SUBSTANTIALLY EQUIVALENT	4
SPES MEDICA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER SPINE
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU HAISHEN MEDICAL DEVICE ASSOCIATES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TECHNOMED EUROPE
	SUBSTANTIALLY EQUIVALENT	1
TEDAN SURGICAL INNOVATIONS INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	22	22
Incorrect, Inadequate or Imprecise Result or Readings	16	16
Adverse Event Without Identified Device or Use Problem	14	14
Device Sensing Problem	12	12
Material Separation	11	11
Failure to Sense	11	11
Break	11	11
Use of Device Problem	9	9
False Negative Result	8	8
Unable to Obtain Readings	7	7
Device Operates Differently Than Expected	5	5
Inappropriate Audible Prompt/Feedback	5	5
Lead(s), burn(s) from	3	3
Material Fragmentation	3	3
Noise, Audible	2	2
Device Unsafe to Use in Environment	2	2
Material Integrity Problem	2	2
False Positive Result	2	2
Flaked	2	2
Connection Problem	2	2
Improper or Incorrect Procedure or Method	1	1
Intermittent Loss of Power	1	1
Loose or Intermittent Connection	1	1
Failure to Analyze Signal	1	1
Overheating of Device	1	1
Physical Resistance/Sticking	1	1
Melted	1	1
Incomplete or Missing Packaging	1	1
Sensing Intermittently	1	1
Mechanical Problem	1	1
Entrapment of Device	1	1
Fire	1	1
Defective Device	1	1
Component Missing	1	1
Unsealed Device Packaging	1	1
Defective Component	1	1
Smoking	1	1
Contamination	1	1
Difficult to Advance	1	1
Fracture	1	1
Appropriate Term/Code Not Available	1	1
Low impedance	1	1
Component or Accessory Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	50	50
Foreign Body In Patient	19	19
No Consequences Or Impact To Patient	19	19
No Known Impact Or Consequence To Patient	13	13
Burn(s)	12	12
Needle Stick/Puncture	7	7
Nerve Damage	6	6
No Information	5	5
Device Embedded In Tissue or Plaque	5	5
Skin Discoloration	3	3
Discomfort	3	3
Unspecified Infection	1	1
No Code Available	1	1
Seizures	1	1
Perforation	1	1
Inflammation	1	1
Cellulitis	1	1
Injury	1	1
Paralysis	1	1
Insufficient Information	1	1
Pain	1	1
Ecchymosis	1	1
Paresis	1	1
Fall	1	1
Laceration(s)	1	1
Bradycardia	1	1
Unspecified Tissue Injury	1	1
Lead(s), Burn(s) From	1	1
Facial Nerve Paralysis	1	1
Low Blood Pressure/ Hypotension	1	1
Full thickness (Third Degree) Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Instruments Div. of Stryker Corporation	II	Sep-03-2010
2	Technomed Europe	II	Jan-07-2022