TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3775	3775
Material Twisted/Bent	1418	1418
Device-Device Incompatibility	699	699
Material Deformation	657	657
Naturally Worn	409	409
Crack	279	279
Fracture	186	186
Appropriate Term/Code Not Available	108	108
Entrapment of Device	104	104
Device Slipped	86	86
Mechanical Jam	85	85
Mechanical Problem	74	74
Material Integrity Problem	72	72
Component Missing	49	49
Contamination /Decontamination Problem	41	41
Scratched Material	35	35
Adverse Event Without Identified Device or Use Problem	28	28
Physical Resistance/Sticking	28	28
Unintended Movement	27	27
Failure to Cut	26	26
Connection Problem	23	23
Detachment of Device or Device Component	19	19
Bent	17	17
Material Split, Cut or Torn	17	17
Material Fragmentation	14	14
No Apparent Adverse Event	14	14
Insufficient Information	12	12
Calibration Problem	12	12
Difficult to Remove	12	12
Structural Problem	12	12
Use of Device Problem	11	11
Corroded	10	10
Torn Material	9	9
Difficult to Insert	7	7
Loose or Intermittent Connection	7	7
Detachment Of Device Component	6	6
Material Discolored	5	5
Material Torqued	5	5
Device Contamination with Chemical or Other Material	5	5
Separation Failure	4	4
Device Operates Differently Than Expected	4	4
Defective Device	4	4
Device Issue	4	4
Improper or Incorrect Procedure or Method	4	4
Output Problem	3	3
Disassembly	3	3
Defective Component	3	3
Separation Problem	3	3
Failure to Disconnect	3	3
Dull, Blunt	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3763	3763
No Consequences Or Impact To Patient	1732	1732
No Known Impact Or Consequence To Patient	753	753
No Information	501	501
Insufficient Information	322	322
Not Applicable	125	125
No Code Available	103	103
Foreign Body In Patient	83	83
Device Embedded In Tissue or Plaque	42	42
No Patient Involvement	41	41
Injury	17	17
Bone Fracture(s)	4	4
Spinal Column Injury	4	4
Limb Fracture	4	4
Local Reaction	3	3
Hip Fracture	2	2
Failure of Implant	2	2
Blood Loss	2	2
Foreign Body Reaction	2	2
Pain	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Neuropathy	1	1
Death	1	1
Burn(s)	1	1
Nerve Damage	1	1
Reaction	1	1
Internal Organ Perforation	1	1
Spinal Cord Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet Microfixation, Inc.	II	Apr-11-2010
2	Biomet U.K., Ltd.	II	Feb-22-2017
3	Smith & Nephew, Inc., Endoscopy Div.	II	Jan-29-2016