TPLC - Total Product Life Cycle

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Device	driver, prosthesis
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HWR
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	2882	2889
Material Twisted/Bent	1797	1798
Device-Device Incompatibility	802	805
Material Deformation	346	346
Naturally Worn	341	344
Crack	177	177
Entrapment of Device	103	104
Mechanical Problem	93	93
Fracture	89	92
Material Integrity Problem	77	78
Mechanical Jam	70	70
No Apparent Adverse Event	70	70
Contamination /Decontamination Problem	36	36
Unintended Movement	30	30
Material Fragmentation	28	28
Failure to Cut	25	25
Detachment of Device or Device Component	22	22
Appropriate Term/Code Not Available	16	16
Adverse Event Without Identified Device or Use Problem	14	14
Corroded	13	13
Illegible Information	12	12
Structural Problem	10	10
Device Slipped	9	9
Scratched Material	8	9
Calibration Problem	4	4
Material Split, Cut or Torn	4	4
Improper or Incorrect Procedure or Method	4	4
Use of Device Problem	3	4
Defective Device	3	3
Insufficient Information	2	2
Failure to Eject	2	2
Flaked	2	2
Material Discolored	1	1
Failure to Align	1	1
Moisture or Humidity Problem	1	2
Difficult to Insert	1	1
Physical Resistance/Sticking	1	1
Device Reprocessing Problem	1	2
Nonstandard Device	1	1
Connection Problem	1	1
Compatibility Problem	1	1
Loose or Intermittent Connection	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5528	5544
Insufficient Information	546	548
Foreign Body In Patient	91	93
Limb Fracture	7	7
Pain	2	2
Unspecified Infection	1	1
Neuropathy	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Bone Fracture(s)	1	1
Foreign Body Reaction	1	1
Burn(s)	1	1
Nerve Damage	1	1