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	3257	3264
Material Twisted/Bent	1998	1999
Device-Device Incompatibility	887	890
Material Deformation	374	374
Naturally Worn	354	357
Crack	212	212
Entrapment of Device	124	125
Fracture	99	102
Mechanical Problem	95	95
Mechanical Jam	91	91
Material Integrity Problem	89	90
No Apparent Adverse Event	70	70
Contamination /Decontamination Problem	45	45
Unintended Movement	35	35
Material Fragmentation	28	28
Failure to Cut	26	26
Detachment of Device or Device Component	25	25
Adverse Event Without Identified Device or Use Problem	23	23
Appropriate Term/Code Not Available	17	17
Corroded	15	15
Scratched Material	14	15
Structural Problem	13	13
Device Slipped	13	13
Illegible Information	12	12
Component Missing	11	11
Calibration Problem	7	7
Physical Resistance/Sticking	7	7
Use of Device Problem	5	6
Material Split, Cut or Torn	4	4
Improper or Incorrect Procedure or Method	4	4
Defective Device	3	3
Loose or Intermittent Connection	3	3
Defective Component	2	2
Insufficient Information	2	2
Failure to Eject	2	2
Flaked	2	2
Difficult to Insert	1	1
Material Discolored	1	1
Failure to Align	1	1
Difficult to Remove	1	1
Moisture or Humidity Problem	1	2
Device Fell	1	1
Material Separation	1	1
Off-Label Use	1	1
Device Reprocessing Problem	1	2
Nonstandard Device	1	1
Connection Problem	1	1
Compatibility Problem	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5654	5670
No Consequences Or Impact To Patient	554	554
Insufficient Information	551	553
Foreign Body In Patient	101	103
No Code Available	86	86
No Patient Involvement	31	31
Limb Fracture	7	7
Not Applicable	6	6
No Information	6	6
No Known Impact Or Consequence To Patient	4	4
Injury	4	4
Pain	2	2
Unspecified Infection	1	1
Neuropathy	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Failure of Implant	1	1
Bone Fracture(s)	1	1
Foreign Body Reaction	1	1
Burn(s)	1	1
Nerve Damage	1	1
Device Embedded In Tissue or Plaque	1	1