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	567	567
Mechanical Problem	495	495
Unintended Movement	355	355
Mechanics Altered	131	131
Unstable	109	109
Loose or Intermittent Connection	92	92
Adverse Event Without Identified Device or Use Problem	82	82
Break	58	58
Physical Resistance/Sticking	29	29
Insufficient Information	16	16
Pressure Problem	9	9
Mechanical Jam	9	9
Fracture	7	7
Decrease in Pressure	7	7
Use of Device Problem	7	7
Unintended System Motion	6	6
Naturally Worn	5	5
Material Integrity Problem	5	5
Device Dislodged or Dislocated	5	5
Material Fragmentation	4	4
Difficult to Open or Close	4	4
Noise, Audible	3	3
Appropriate Term/Code Not Available	3	3
No Apparent Adverse Event	3	3
Output Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Dull, Blunt	3	3
Defective Component	3	3
Material Too Rigid or Stiff	3	3
Component Missing	2	2
Difficult to Remove	2	2
Retraction Problem	2	2
Material Discolored	2	2
Material Split, Cut or Torn	2	2
Unclear Information	2	2
Improper or Incorrect Procedure or Method	1	1
Migration or Expulsion of Device	1	1
Material Separation	1	1
Peeled/Delaminated	1	1
Increase in Pressure	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Detachment of Device or Device Component	1	1
Connection Problem	1	1
Component or Accessory Incompatibility	1	1
Calibration Problem	1	1
Malposition of Device	1	1
Defective Device	1	1
No Pressure	1	1
Failure to Align	1	1
Positioning Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	750	750
Laceration(s)	545	545
No Known Impact Or Consequence To Patient	309	309
No Consequences Or Impact To Patient	201	201
Insufficient Information	43	43
No Patient Involvement	43	43
Unspecified Tissue Injury	22	22
Injury	15	15
Skull Fracture	13	13
Hemorrhage/Bleeding	11	11
Needle Stick/Puncture	9	9
Skin Tears	7	7
Abrasion	7	7
Hematoma	7	7
Bone Fracture(s)	3	3
Suture Abrasion	2	2
Hyperextension	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Bruise/Contusion	2	2
No Code Available	2	2
Irritation	1	1
Pain	1	1
Paresis	1	1
Skin Discoloration	1	1
Brain Injury	1	1
Spinal Cord Injury	1	1
Intervertebral Disc Compression or Protrusion	1	1
Skin Disorders	1	1
Bacterial Infection	1	1
Bradycardia	1	1
Ecchymosis	1	1
Intracranial Hemorrhage	1	1
Failure of Implant	1	1
No Information	1	1
Cerebral Edema	1	1