TPLC - Total Product Life Cycle

show TPLC since

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	582	582
Mechanical Problem	312	312
Unintended Movement	202	202
Unstable	150	150
Mechanics Altered	143	143
Adverse Event Without Identified Device or Use Problem	66	66
Loose or Intermittent Connection	34	34
Break	24	24
Physical Resistance/Sticking	15	15
Insufficient Information	12	12
Mechanical Jam	11	11
Pressure Problem	7	7
Device Dislodged or Dislocated	6	6
Use of Device Problem	6	6
Unintended System Motion	5	5
Difficult to Open or Close	4	4
Fracture	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Appropriate Term/Code Not Available	3	3
Material Fragmentation	3	3
No Apparent Adverse Event	3	3
Decrease in Pressure	3	3
Noise, Audible	2	2
Material Split, Cut or Torn	2	2
Naturally Worn	2	2
Unclear Information	2	2
Defective Component	2	2
Component Missing	2	2
Detachment of Device or Device Component	2	2
Dull, Blunt	1	1
Improper or Incorrect Procedure or Method	1	1
Failure to Cycle	1	1
Increase in Pressure	1	1
Activation Failure	1	1
Retraction Problem	1	1
Device Handling Problem	1	1
Misassembly by Users	1	1
Calibration Problem	1	1
Sharp Edges	1	1
Failure to Align	1	1
Material Too Rigid or Stiff	1	1
Degraded	1	1
Ejection Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Difficult to Remove	1	1
Positioning Problem	1	1
Defective Device	1	1
Vibration	1	1
Patient-Device Incompatibility	1	1
Peeled/Delaminated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	803	803
Laceration(s)	553	553
Insufficient Information	65	65
No Known Impact Or Consequence To Patient	53	53
Unspecified Tissue Injury	32	32
No Consequences Or Impact To Patient	17	17
Skull Fracture	14	14
Hemorrhage/Bleeding	12	12
Abrasion	9	9
Needle Stick/Puncture	9	9
No Patient Involvement	8	8
Skin Tears	7	7
Hematoma	6	6
Bone Fracture(s)	2	2
Hyperextension	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Failure of Implant	1	1
Brain Injury	1	1
Head Injury	1	1
Muscle Weakness	1	1
Skin Disorders	1	1
Movement Disorder	1	1
Intracranial Hemorrhage	1	1
Ecchymosis	1	1
Paresis	1	1
Bradycardia	1	1
Increased Respiratory Rate	1	1
Cerebrospinal Fluid Leakage	1	1
Neck Stiffness	1	1
Intervertebral Disc Compression or Protrusion	1	1
Bacterial Infection	1	1
Pressure Sores	1	1
Spinal Cord Injury	1	1
Bruise/Contusion	1	1
Cerebral Edema	1	1