TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Contamination	33	33
Device Misassembled During Manufacturing /Shipping	29	29
Material Integrity Problem	21	21
Component Missing	20	20
Material Separation	17	17
Contamination /Decontamination Problem	14	14
Material Frayed	10	10
Manufacturing, Packaging or Shipping Problem	9	9
Detachment of Device or Device Component	8	8
Device Contaminated During Manufacture or Shipping	4	4
Separation Problem	4	4
Flaked	4	4
Delivered as Unsterile Product	3	3
Inadequacy of Device Shape and/or Size	3	3
Appropriate Term/Code Not Available	3	3
Extra Components	3	3
Break	2	2
Incomplete or Missing Packaging	2	2
Failure to Sense	2	2
Defective Device	2	2
Material Discolored	2	2
Use of Device Problem	2	2
Compatibility Problem	1	1
Material Split, Cut or Torn	1	1
Peeled/Delaminated	1	1
Device Damaged Prior to Use	1	1
Material Disintegration	1	1
Fail-Safe Did Not Operate	1	1
Scratched Material	1	1
Material Fragmentation	1	1
Material Deformation	1	1
Packaging Problem	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	107	107
No Consequences Or Impact To Patient	46	46
No Known Impact Or Consequence To Patient	34	34
Insufficient Information	9	9
Nausea	4	4
Headache	4	4
No Information	3	3
Failure of Implant	2	2
Vomiting	2	2
No Patient Involvement	2	2
Dizziness	1	1
Presyncope	1	1
Inflammation	1	1
Foreign Body In Patient	1	1
Bradycardia	1	1
Nasal Obstruction	1	1
Therapeutic Effects, Unexpected	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