TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Slipped	647	647
Mechanical Problem	496	496
Unintended Movement	357	357
Unstable	143	143
Mechanics Altered	137	137
Loose or Intermittent Connection	92	92
Adverse Event Without Identified Device or Use Problem	83	83
Break	59	59
Physical Resistance/Sticking	29	29
Insufficient Information	18	18
Mechanical Jam	10	10
Pressure Problem	9	9
Fracture	7	7
Decrease in Pressure	7	7
Use of Device Problem	7	7
Difficult to Open or Close	6	6
Unintended System Motion	6	6
Device Dislodged or Dislocated	6	6
Naturally Worn	5	5
Material Integrity Problem	5	5
Material Fragmentation	4	4
Noise, Audible	3	3
Dull, Blunt	3	3
Appropriate Term/Code Not Available	3	3
No Apparent Adverse Event	3	3
Material Too Rigid or Stiff	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Defective Component	3	3
Output Problem	3	3
Difficult to Remove	2	2
Material Discolored	2	2
Component Missing	2	2
Unclear Information	2	2
Retraction Problem	2	2
Detachment of Device or Device Component	2	2
Material Split, Cut or Torn	2	2
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Ejection Problem	1	1
Positioning Problem	1	1
Degraded	1	1
No Pressure	1	1
Defective Device	1	1
Vibration	1	1
Failure to Align	1	1
Sharp Edges	1	1
Calibration Problem	1	1
Misassembly by Users	1	1
Device Handling Problem	1	1
Material Separation	1	1
Material Disintegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	792	792
Laceration(s)	613	613
No Known Impact Or Consequence To Patient	309	309
No Consequences Or Impact To Patient	201	201
Insufficient Information	54	54
No Patient Involvement	43	43
Unspecified Tissue Injury	27	27
Injury	15	15
Skull Fracture	14	14
Hemorrhage/Bleeding	12	12
Abrasion	9	9
Needle Stick/Puncture	9	9
Skin Tears	7	7
Hematoma	7	7
Bone Fracture(s)	3	3
Bruise/Contusion	2	2
Hyperextension	2	2
Suture Abrasion	2	2
No Code Available	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Irritation	1	1
Movement Disorder	1	1
Skin Discoloration	1	1
Intracranial Hemorrhage	1	1
Skin Disorders	1	1
Head Injury	1	1
Pain	1	1
Muscle Weakness	1	1
Ecchymosis	1	1
Paresis	1	1
Bradycardia	1	1
No Information	1	1
Brain Injury	1	1
Intervertebral Disc Compression or Protrusion	1	1
Neck Stiffness	1	1
Cerebrospinal Fluid Leakage	1	1
Failure of Implant	1	1
Bacterial Infection	1	1
Pressure Sores	1	1
Spinal Cord Injury	1	1
Cerebral Edema	1	1