TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
MCEWEN AND ASSOCIATES CONSULTING , LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	265	265
Decrease in Pressure	200	777
Gas/Air Leak	112	112
Delivered as Unsterile Product	49	49
Pressure Problem	45	45
Measurement System Incompatibility	44	44
Deflation Problem	37	37
Increase in Pressure	17	27
Material Split, Cut or Torn	12	12
Packaging Problem	11	11
Patient Device Interaction Problem	11	11
No Apparent Adverse Event	11	11
Device Alarm System	8	8
Infusion or Flow Problem	6	6
Output Problem	6	6
Material Puncture/Hole	6	6
Expiration Date Error	5	5
Component Missing	5	5
Use of Device Problem	5	5
Noise, Audible	5	5
Inflation Problem	5	5
Application Program Version or Upgrade Problem	5	5
Material Frayed	4	4
Calibration Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Insufficient Device Problem Information	3	3
Therapeutic or Diagnostic Output Failure	3	3
Incorrect Measurement	3	3
Protective Measures Problem	3	3
Computer Software Problem	3	3
Break	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Unintended Deflation	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Display or Visual Feedback Problem	2	2
Intermittent Loss of Power	2	2
Battery Problem	2	2
Charging Problem	2	2
Detachment of Device or Device Component	2	2
Thermal Decomposition of Device	2	2
Material Deformation	2	2
Power Problem	1	1
Device Fell	1	1
No Pressure	1	1
Naturally Worn	1	1
Material Twisted/Bent	1	1
Material Integrity Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Inadequate User Interface	1	1
Failure to Shut Off	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	719	1301
Insufficient Information	80	434
Blister	8	8
Hemorrhage/Blood Loss/Bleeding	7	19
Skin Discoloration	5	5
Swelling/ Edema	4	4
Bruise/Contusion	4	6
No Patient Involvement	3	3
Pain	3	3
Hematoma	2	2
Erythema	2	2
Numbness	2	2
Localized Skin Lesion	1	1
Low Blood Pressure/ Hypotension	1	1
Muscle/Tendon Damage	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Burn(s)	1	1
Exsanguination	1	1
Tissue Breakdown	1	1
Convulsion/Seizure	1	1
Laceration(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Corporation	II	Aug-07-2025
2	Stryker Corporation	II	Apr-04-2023
3	Stryker Sustainability Solutions	II	Apr-09-2026
4	Stryker Sustainability Solutions	II	Jul-17-2024
5	Stryker Sustainability Solutions	II	Apr-01-2023
6	Stryker Sustainability Solutions	II	Feb-22-2022
7	Zimmer Surgical Inc	II	Jul-02-2026
8	Zimmer Surgical Inc	II	Jan-28-2026