TPLC - Total Product Life Cycle

show TPLC since

Device	motor, drill, pneumatic
Regulation Description	Pneumatic cranial drill motor.
Product Code	HBB
Regulation Number	882.4370
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	954	1473
Detachment of Device or Device Component	685	735
No Apparent Adverse Event	227	228
Naturally Worn	138	138
Difficult to Insert	134	134
Material Puncture/Hole	109	109
Noise, Audible	100	100
Fluid/Blood Leak	86	390
Fracture	76	77
Vibration	69	69
Break	64	64
Output below Specifications	64	64
Physical Resistance/Sticking	63	64
Loss of Power	62	62
Difficult to Remove	58	58
Material Twisted/Bent	44	44
Unintended System Motion	42	42
Corroded	36	36
Excessive Heating	36	36
Device Remains Activated	34	34
Complete Loss of Power	30	30
Fail-Safe Did Not Operate	27	27
Electrical /Electronic Property Problem	25	25
Burst Container or Vessel	23	31
Appropriate Term/Code Not Available	20	20
Leak/Splash	16	16
Product Quality Problem	13	13
Mechanical Jam	13	13
Adverse Event Without Identified Device or Use Problem	11	11
Material Deformation	11	11
Premature Separation	10	10
Smoking	10	10
Unintended Power Up	10	15
Device Displays Incorrect Message	9	9
Misconnection	9	9
Material Rupture	8	8
Fail-Safe Problem	7	8
Material Fragmentation	6	6
Device-Device Incompatibility	4	4
Gas/Air Leak	4	4
Device Contaminated During Manufacture or Shipping	3	3
Material Integrity Problem	3	3
Insufficient Information	3	3
Dull, Blunt	3	3
Degraded	3	3
Device Reprocessing Problem	2	2
Mechanical Problem	2	2
Energy Output Problem	2	2
Explosion	2	2
Intermittent Loss of Power	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2424	3310
Insufficient Information	137	273
Unintended Radiation Exposure	15	16
Burn(s)	12	12
Device Embedded In Tissue or Plaque	10	10
Chemical Exposure	6	6
Unspecified Infection	5	5
Unspecified Tissue Injury	5	5
Perforation	4	4
Cerebrospinal Fluid Leakage	3	3
Tinnitus	3	3
Pain	2	2
Partial thickness (Second Degree) Burn	2	4
Hemorrhage/Bleeding	2	2
Spinal Cord Injury	2	2
Nicks, cuts or tears of dura or other tissues by device	1	1
Muscle Weakness	1	1
Intracranial Hemorrhage	1	1
Oversedation	1	1
Foreign Body In Patient	1	1
Nerve Damage	1	1
Numbness	1	1
Awareness during Anaesthesia	1	1
Laceration(s)	1	1
Paresis	1	1
Reaction	1	1
Bacterial Infection	1	1
Hormonal Imbalance	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap AG	II	Oct-02-2025