TPLC - Total Product Life Cycle

• Device: instrument, surgical, non-powered
• Regulation Description: Nonpowered neurosurgical instrument.
• Product Code: HAO
• Regulation Number: 882.4535
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2017	26	26
2018	10	10
2019	19	19
2020	7	7
2021	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	43	43
Material Integrity Problem	5	5
Material Puncture/Hole	4	4
Detachment of Device or Device Component	3	3
Tear, Rip or Hole in Device Packaging	2	2
Fracture	2	2
Contamination /Decontamination Problem	2	2
Material Twisted/Bent	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Explosion	1	1
Material Split, Cut or Torn	1	1
Physical Resistance/Sticking	1	1
Material Fragmentation	1	1
Incorrect Measurement	1	1
Mechanical Problem	1	1
Unintended Collision	1	1
Detachment Of Device Component	1	1
Component Falling	1	1
Degraded	1	1
Separation Failure	1	1
Difficult to Open or Remove Packaging Material	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Difficult to Remove	1	1
Retraction Problem	1	1
Metal Shedding Debris	1	1
Component Missing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	29	29
No Known Impact Or Consequence To Patient	17	17
No Patient Involvement	6	6
Foreign Body In Patient	5	5
No Clinical Signs, Symptoms or Conditions	5	5
No Information	4	4
Device Embedded In Tissue or Plaque	2	2
Laceration(s)	1	1
No Code Available	1	1
Hydrocephalus	1	1
Insufficient Information	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Patient Problem/Medical Problem	1	1
Injury	1	1
Osteolysis	1	1