TPLC - Total Product Life Cycle

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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	20	20
Adverse Event Without Identified Device or Use Problem	14	14
Device Sensing Problem	12	12
Break	11	11
Failure to Sense	11	11
Material Separation	11	11
Use of Device Problem	9	9
Unable to Obtain Readings	7	7
Incorrect, Inadequate or Imprecise Result or Readings	7	7
False Negative Result	5	5
Device Operates Differently Than Expected	5	5
Inappropriate Audible Prompt/Feedback	5	5
Material Fragmentation	3	3
Lead(s), burn(s) from	3	3
Flaked	2	2
Device Unsafe to Use in Environment	2	2
Connection Problem	2	2
Material Integrity Problem	2	2
Noise, Audible	2	2
Physical Resistance/Sticking	1	1
Intermittent Loss of Power	1	1
Appropriate Term/Code Not Available	1	1
Difficult to Advance	1	1
Low impedance	1	1
Defective Component	1	1
Component Missing	1	1
Incomplete or Missing Packaging	1	1
Defective Device	1	1
Component or Accessory Incompatibility	1	1
Improper or Incorrect Procedure or Method	1	1
Fracture	1	1
Smoking	1	1
Failure to Analyze Signal	1	1
Sensing Intermittently	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Melted	1	1
Overheating of Device	1	1
Unsealed Device Packaging	1	1
Fire	1	1
Contamination	1	1
Entrapment of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	39	39
No Consequences Or Impact To Patient	19	19
Foreign Body In Patient	17	17
No Known Impact Or Consequence To Patient	13	13
Burn(s)	12	12
Needle Stick/Puncture	7	7
Device Embedded In Tissue or Plaque	5	5
No Information	5	5
Nerve Damage	5	5
Discomfort	3	3
Skin Discoloration	3	3
Bradycardia	1	1
Injury	1	1
Pain	1	1
Paralysis	1	1
Paresis	1	1
Perforation	1	1
Seizures	1	1
Cellulitis	1	1
Ecchymosis	1	1
Facial Nerve Paralysis	1	1
Fall	1	1
Low Blood Pressure/ Hypotension	1	1
Unspecified Infection	1	1
Inflammation	1	1
Laceration(s)	1	1
No Code Available	1	1
Unspecified Tissue Injury	1	1
Insufficient Information	1	1
Full thickness (Third Degree) Burn	1	1
Lead(s), Burn(s) From	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