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	321	322
Device-Device Incompatibility	237	239
Material Deformation	186	188
Naturally Worn	155	155
Scratched Material	63	63
Material Integrity Problem	29	29
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
Failure to Cut	7	8
Entrapment of Device	4	4
Unintended Movement	4	4
Structural Problem	4	4
Material Discolored	3	3
Improper or Incorrect Procedure or Method	3	3
Patient-Device Incompatibility	2	2
Use of Device Problem	2	2
Appropriate Term/Code Not Available	2	2
Device Slipped	1	1
Mechanical Problem	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	870	874
Insufficient Information	107	107
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