TPLC - Total Product Life Cycle

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Device	instrument, cutting, orthopedic
Regulation Description	Manual surgical instrument for general use.
Product Code	HTZ
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	339	340
Device-Device Incompatibility	238	240
Material Deformation	187	189
Naturally Worn	155	155
Failure to Cut	80	81
Scratched Material	63	63
Material Integrity Problem	30	30
Crack	25	25
Mechanical Jam	20	20
Corroded	15	15
Material Twisted/Bent	14	14
No Apparent Adverse Event	14	14
Detachment of Device or Device Component	13	13
Illegible Information	10	10
Contamination /Decontamination Problem	9	10
Adverse Event Without Identified Device or Use Problem	9	9
Incorrect Measurement	9	9
Entrapment of Device	4	4
Unintended Movement	4	4
Structural Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Material Discolored	3	3
Mechanical Problem	2	2
Patient-Device Incompatibility	2	2
Use of Device Problem	2	2
Appropriate Term/Code Not Available	2	2
Device Slipped	1	1
Off-Label Use	1	1
Difficult to Advance	1	1
Positioning Problem	1	1
Material Fragmentation	1	1
Device Reprocessing Problem	1	1
Self-Activation or Keying	1	1
Failure to Disconnect	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	959	963
Insufficient Information	111	111
Unspecified Tissue Injury	3	3
Post Operative Wound Infection	2	2
Foreign Body In Patient	2	2
Hemorrhage/Bleeding	2	2
Paralysis	1	1
Nerve Damage	1	1
Pain	1	1
Cerebrospinal Fluid Leakage	1	1
Spinal Cord Injury	1	1