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	364	365
Device-Device Incompatibility	205	205
Contamination /Decontamination Problem	70	70
Fracture	48	50
Material Deformation	25	25
Failure to Cut	24	24
Entrapment of Device	17	17
Material Separation	11	11
Appropriate Term/Code Not Available	10	10
Crack	10	10
Material Fragmentation	9	9
Material Twisted/Bent	9	9
Adverse Event Without Identified Device or Use Problem	9	9
Material Integrity Problem	8	8
Mechanical Jam	7	7
Detachment of Device or Device Component	6	6
Mechanical Problem	4	4
Device Contamination with Chemical or Other Material	4	4
Dull, Blunt	3	3
Corroded	3	3
Material Split, Cut or Torn	3	3
Difficult to Remove	3	3
Use of Device Problem	3	3
Device Handling Problem	3	3
Naturally Worn	2	2
No Apparent Adverse Event	2	2
Mechanics Altered	1	1
Device Difficult to Maintain	1	1
Difficult to Insert	1	1
Patient-Device Incompatibility	1	1
Separation Failure	1	1
Material Puncture/Hole	1	1
Migration	1	1
Illegible Information	1	1
Physical Resistance/Sticking	1	1
Device Contaminated During Manufacture or Shipping	1	1
Device Or Device Fragments Location Unknown	1	1
Compatibility Problem	1	1
Expulsion	1	1
Fitting Problem	1	1
Detachment Of Device Component	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	476	479
No Consequences Or Impact To Patient	127	127
No Patient Involvement	78	78
Foreign Body In Patient	47	47
Insufficient Information	29	29
No Known Impact Or Consequence To Patient	22	22
No Code Available	11	11
Bone Fracture(s)	5	5
Injury	5	5
Device Embedded In Tissue or Plaque	4	4
Pain	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unspecified Infection	1	1
Patient Problem/Medical Problem	1	1
Not Applicable	1	1
Post Operative Wound Infection	1	1
Nerve Damage	1	1
Infiltration into Tissue	1	1