TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Contamination	41	41
Material Integrity Problem	16	16
Material Separation	15	15
Component Missing	11	11
Detachment of Device or Device Component	7	7
Insufficient Information	5	5
Contamination /Decontamination Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Nonstandard Device	5	5
Material Frayed	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Separation Problem	3	3
Flaked	3	3
Extra Components	3	3
Material Split, Cut or Torn	2	2
Material Discolored	2	2
Use of Device Problem	2	2
Appropriate Term/Code Not Available	2	2
Compatibility Problem	1	2
Device Contaminated During Manufacture or Shipping	1	1
Break	1	1
Peeled/Delaminated	1	1
Device Damaged Prior to Use	1	1
Material Disintegration	1	1
Fail-Safe Did Not Operate	1	1
Failure to Sense	1	1
Defective Device	1	1
Material Fragmentation	1	1
Delivered as Unsterile Product	1	1
Component Misassembled	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	111	112
Insufficient Information	9	9
Nausea	8	8
Headache	8	8
High Blood Pressure/ Hypertension	4	4
Impaired Healing	4	4
Wound Dehiscence	4	4
Foreign Body In Patient	4	4
Erythema	4	4
Fluid Discharge	4	4
Dysphagia/ Odynophagia	4	4
Swelling/ Edema	4	4
Convulsion/Seizure	4	4
Hemorrhage/Bleeding	4	4
Dizziness	3	3
Vomiting	3	3
Pain	2	2
Bradycardia	2	2
Presyncope	1	1
Inflammation	1	1
No Known Impact Or Consequence To Patient	1	1
Nasal Obstruction	1	1
Airway Obstruction	1	1
Device Embedded In Tissue or Plaque	1	1
Unintended Radiation Exposure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	American Surgical Company, LLC	II	Nov-01-2024
2	Integra LifeSciences Corp.	II	Oct-29-2024
3	Integra LifeSciences Corp.	II	Jan-06-2023
4	Medline Industries, LP	II	Apr-30-2026