TPLC - Total Product Life Cycle

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Device	extractor
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HWB
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	732	734
Device-Device Incompatibility	363	364
Material Deformation	197	197
Naturally Worn	129	129
Material Twisted/Bent	105	105
Fracture	72	72
Mechanical Jam	52	52
Crack	48	48
Material Integrity Problem	34	34
No Apparent Adverse Event	31	31
Entrapment of Device	15	15
Mechanical Problem	12	12
Contamination /Decontamination Problem	11	12
Corroded	11	12
Structural Problem	8	8
Detachment of Device or Device Component	8	8
Scratched Material	7	7
Illegible Information	7	7
Use of Device Problem	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Device Slipped	5	5
Unintended Movement	5	5
Difficult to Remove	5	5
Difficult to Open or Close	5	5
Failure to Cut	3	3
Material Fragmentation	2	2
Mechanics Altered	2	2
Device Handling Problem	2	2
Appropriate Term/Code Not Available	2	2
Improper or Incorrect Procedure or Method	2	2
Off-Label Use	1	1
Output Problem	1	1
Activation Problem	1	1
Device Damaged Prior to Use	1	1
Defective Component	1	1
Defective Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Degraded	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1439	1441
Insufficient Information	196	197
Foreign Body In Patient	21	21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Bone Fracture(s)	5	5
Failure of Implant	4	4
Unspecified Tissue Injury	3	3
Unspecified Infection	2	2
Muscle Weakness	2	2
Unspecified Nervous System Problem	2	2
Seroma	2	2
Numbness	2	2
Pain	2	2
Cerebrospinal Fluid Leakage	2	2
Rheumatoid Arthritis	1	1
Necrosis	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Innomed, Inc.	II	May-01-2024