TPLC - Total Product Life Cycle

show TPLC since

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	198	198
Device-Device Incompatibility	153	153
Contamination /Decontamination Problem	40	40
Fracture	32	32
Entrapment of Device	12	12
Crack	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Material Fragmentation	6	6
Material Integrity Problem	5	5
Failure to Cut	5	5
Mechanical Jam	4	4
Material Twisted/Bent	3	3
Material Separation	3	3
Appropriate Term/Code Not Available	3	3
Dull, Blunt	3	3
Material Split, Cut or Torn	2	2
Difficult to Remove	2	2
Use of Device Problem	2	2
Material Deformation	2	2
No Apparent Adverse Event	2	2
Naturally Worn	2	2
Corroded	2	2
Device Slipped	1	1
Fitting Problem	1	1
Expulsion	1	1
Compatibility Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Separation Failure	1	1
Detachment of Device or Device Component	1	1
Illegible Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	347	347
No Consequences Or Impact To Patient	42	42
Foreign Body In Patient	26	26
No Patient Involvement	24	24
Insufficient Information	19	19
No Known Impact Or Consequence To Patient	5	5
Bone Fracture(s)	4	4
Injury	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Code Available	2	2
Device Embedded In Tissue or Plaque	2	2
Not Applicable	1	1
Post Operative Wound Infection	1	1