TPLC - Total Product Life Cycle

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Device	tap, bone
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HWX
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	188	189
Device-Device Incompatibility	135	135
Contamination /Decontamination Problem	41	41
Fracture	34	36
Material Deformation	25	25
Entrapment of Device	10	10
Material Separation	8	8
Crack	7	7
Material Integrity Problem	7	7
Material Twisted/Bent	7	7
Material Fragmentation	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Mechanical Problem	4	4
Failure to Cut	4	4
Mechanical Jam	4	4
Material Split, Cut or Torn	3	3
Difficult to Remove	3	3
Detachment of Device or Device Component	3	3
Use of Device Problem	2	2
No Apparent Adverse Event	2	2
Appropriate Term/Code Not Available	2	2
Naturally Worn	2	2
Corroded	2	2
Device Slipped	1	1
Fitting Problem	1	1
Expulsion	1	1
Device Contaminated During Manufacture or Shipping	1	1
Separation Failure	1	1
Illegible Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	405	408
Insufficient Information	27	27
Foreign Body In Patient	22	22
Bone Fracture(s)	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Device Embedded In Tissue or Plaque	2	2
Post Operative Wound Infection	1	1
No Known Impact Or Consequence To Patient	1	1
Infiltration into Tissue	1	1