TPLC - Total Product Life Cycle

show TPLC since

Device	drills, burrs, trephines & accessories (manual)
Product Code	HBG
Regulation Number	882.4300
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	5	5
Break	4	4
Difficult to Remove	3	3
Device-Device Incompatibility	3	3
Appropriate Term/Code Not Available	3	3
Unintended Movement	2	2
Overheating of Device	2	2
Material Integrity Problem	2	2
Material Discolored	2	2
Component Missing	2	2
Component or Accessory Incompatibility	2	2
Device Operates Differently Than Expected	1	1
Device Packaging Compromised	1	1
Kinked	1	1
Mechanical Problem	1	1
Packaging Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Shipping Damage or Problem	1	1
Failure to Eject	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8	8
No Known Impact Or Consequence To Patient	7	7
No Code Available	4	4
No Consequences Or Impact To Patient	3	3
Insufficient Information	2	2
Hypersensitivity/Allergic reaction	2	2
Skin Irritation	2	2
Headache, Lumbar Puncture	1	1
Failure of Implant	1	1
Unspecified Infection	1	1
Bacterial Infection	1	1
Burn(s)	1	1
Cerebrospinal Fluid Leakage	1	1
Hematoma	1	1
Intracranial Hemorrhage	1	1
Unspecified Tissue Injury	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ad-Tech Medical Instrument Corporation	II	Sep-13-2019
2	Instrumed International, Inc.	II	Dec-16-2014
3	Integra Life Sciences Corporation	II	Sep-21-2009
4	Integra LifeSciences Corp.	II	Feb-28-2024
5	Integra LifeSciences Corp.	II	Dec-06-2023
6	Integra LifeSciences Corp.	III	May-13-2011
7	Integra LifeSciences Corp.	II	May-10-2011
8	Integra LifeSciences Corp. d.b.a. Integra Pain Management	II	Sep-02-2016
9	Integra LifeSciences Corp. d.b.a. Integra Pain Management	II	Jan-13-2012
10	Integra Limited	II	Aug-26-2013