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	196	776
Gas/Air Leak	116	116
Delivered as Unsterile Product	49	49
Pressure Problem	48	48
Measurement System Incompatibility	42	42
Deflation Problem	37	37
Increase in Pressure	17	28
Inflation Problem	14	14
Material Split, Cut or Torn	12	12
Patient Device Interaction Problem	12	12
No Apparent Adverse Event	11	11
Packaging Problem	11	11
Device Alarm System	9	9
Output Problem	8	8
Material Puncture/Hole	7	7
Infusion or Flow Problem	6	6
Therapeutic or Diagnostic Output Failure	6	6
Component Missing	6	6
Use of Device Problem	6	6
Noise, Audible	5	5
Break	5	5
Calibration Problem	5	5
Application Program Version or Upgrade Problem	5	5
Expiration Date Error	5	5
Product Quality Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Material Frayed	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Unintended Deflation	3	3
Protective Measures Problem	3	3
Computer Software Problem	3	3
Insufficient Information	3	3
Incorrect Measurement	3	3
Battery Problem	2	2
No Pressure	2	2
Self-Activation or Keying	2	2
Display or Visual Feedback Problem	2	2
Appropriate Term/Code Not Available	2	2
Thermal Decomposition of Device	2	2
Charging Problem	2	2
Patient-Device Incompatibility	2	2
Intermittent Loss of Power	2	2
Material Deformation	2	2
Detachment of Device or Device Component	2	2
Naturally Worn	1	1
Connection Problem	1	1
Power Problem	1	1
Low Audible Alarm	1	1
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	709	1295
Insufficient Information	78	435
Blister	8	8
Hemorrhage/Bleeding	7	22
Skin Discoloration	5	5
Bruise/Contusion	4	6
Swelling/ Edema	4	4
Pain	3	3
No Patient Involvement	3	3
Numbness	2	2
Hematoma	2	2
Erythema	2	2
Exsanguination	1	1
Burn(s)	1	1
Low Blood Pressure/ Hypotension	1	1
Laceration(s)	1	1
Localized Skin Lesion	1	1
Tissue Breakdown	1	1
Convulsion/Seizure	1	1
Muscle/Tendon Damage	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	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	Jul-17-2024
4	Stryker Sustainability Solutions	II	Apr-01-2023
5	Stryker Sustainability Solutions	II	Feb-22-2022
6	Zimmer Surgical Inc	II	Jan-28-2026