TPLC - Total Product Life Cycle

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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	983	1500
Detachment of Device or Device Component	862	912
No Apparent Adverse Event	284	285
Naturally Worn	233	233
Difficult to Insert	208	208
Material Puncture/Hole	109	109
Noise, Audible	109	109
Fluid/Blood Leak	93	397
Fracture	83	84
Loss of Power	78	78
Vibration	75	75
Physical Resistance/Sticking	74	75
Difficult to Remove	73	73
Output below Specifications	63	63
Break	55	55
Material Twisted/Bent	45	45
Unintended System Motion	44	44
Corroded	39	39
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	26	26
Burst Container or Vessel	22	30
Appropriate Device Problem Term/Code Not Available	20	20
Leak/Splash	16	16
Product Quality Problem	13	13
Mechanical Jam	13	13
Material Deformation	12	12
Material Rupture	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Premature Separation	10	10
Unintended Power Up	10	15
Misconnection	9	9
Device Displays Incorrect Message	9	9
Smoking	8	8
Fail-Safe Problem	7	8
Material Fragmentation	5	5
Gas/Air Leak	5	5
Material Integrity Problem	5	5
Device-Device Incompatibility	4	4
Degraded	3	3
Insufficient Device Problem Information	3	3
Device Contaminated During Manufacture or Shipping	3	3
Dull, Blunt	3	3
Device Reprocessing Problem	2	2
Intermittent Loss of Power	2	2
Component Missing	2	2
Mechanical Problem	2	2
Energy Output Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2855	3739
Insufficient Information	175	311
Unintended Radiation Exposure	15	16
Burn(s)	12	12
Device Embedded In Tissue or Plaque	11	11
Unspecified Tissue Injury	6	6
Chemical Exposure	6	6
Unspecified Infection	5	5
Perforation	4	4
Tinnitus	3	3
Cerebrospinal Fluid Leakage	3	3
Spinal Cord Injury	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Pain	2	2
Partial thickness (Second Degree) Burn	2	4
Reaction	1	1
Awareness during Anaesthesia	1	1
Dural Tear	1	1
Nerve Damage	1	1
Muscle Weakness/Atrophy	1	1
Bacterial Infection	1	1
Intracranial Hemorrhage	1	1
Oversedation	1	1
Laceration(s)	1	1
Numbness	1	1
Hormonal Imbalance	1	1
Paresis	1	1
Foreign Body In Patient	1	1

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