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	755	757
Device-Device Incompatibility	375	376
Material Deformation	205	205
Naturally Worn	129	129
Material Twisted/Bent	113	113
Fracture	74	74
Mechanical Jam	52	52
Crack	49	49
Material Integrity Problem	36	36
No Apparent Adverse Event	32	32
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
Component Missing	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	1488	1490
Insufficient Information	198	199
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