TPLC - Total Product Life Cycle

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Device	holder, head, neurosurgical (skull clamp)
Product Code	HBL
Regulation Number	882.4460
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	994	994
Mechanical Problem	651	651
Device Slipped	574	574
Mechanics Altered	128	128
Loose or Intermittent Connection	120	120
Break	106	106
Adverse Event Without Identified Device or Use Problem	84	84
Unstable	63	63
Physical Resistance/Sticking	40	40
Use of Device Problem	26	26
Insufficient Information	20	20
Mechanical Jam	18	18
Device Handling Problem	17	17
Crack	17	17
Material Integrity Problem	11	11
Pressure Problem	10	10
Fracture	10	10
Naturally Worn	9	9
Decrease in Pressure	9	9
Detachment of Device or Device Component	7	7
Unintended System Motion	6	6
Noise, Audible	6	6
Difficult to Open or Close	5	5
Material Too Soft/Flexible	5	5
Device Dislodged or Dislocated	5	5
Material Too Rigid or Stiff	4	4
Material Fragmentation	4	4
Dull, Blunt	3	3
Defective Component	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Positioning Problem	3	3
No Apparent Adverse Event	3	3
Defective Device	3	3
Appropriate Term/Code Not Available	3	3
Output Problem	3	3
Material Discolored	2	2
Difficult to Remove	2	2
Component Missing	2	2
Material Separation	2	2
Compatibility Problem	2	2
Retraction Problem	2	2
Unclear Information	2	2
Material Deformation	2	2
Material Split, Cut or Torn	2	2
Improper or Incorrect Procedure or Method	1	1
Disconnection	1	1
Separation Problem	1	1
Connection Problem	1	1
Device Reprocessing Problem	1	1
Component or Accessory Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	1052	1052
No Clinical Signs, Symptoms or Conditions	681	681
Laceration(s)	568	568
No Known Impact Or Consequence To Patient	331	331
No Patient Involvement	81	81
Injury	45	45
Insufficient Information	23	23
Skull Fracture	13	13
Unspecified Tissue Injury	11	11
Hemorrhage/Bleeding	11	11
Needle Stick/Puncture	9	9
Skin Tears	7	7
Hematoma	5	5
Bone Fracture(s)	3	3
Abrasion	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Code Available	2	2
No Information	2	2
Suture Abrasion	2	2
Contusion	2	2
Hyperextension	2	2
Bruise/Contusion	2	2
Failure of Implant	1	1
Skin Discoloration	1	1
Irritation	1	1
Intracranial Hemorrhage	1	1
Radiation Underdose	1	1
Fall	1	1
Pain	1	1
Missing Value Reason	1	1
Intervertebral Disc Compression or Protrusion	1	1
Spinal Cord Injury	1	1