TPLC - Total Product Life Cycle

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Device	drills, burrs, trephines & accessories (compound, powered)
Regulation Description	Powered compound cranial drills, burrs, trephines, and their accessories.
Product Code	HBF
Regulation Number	882.4305
Device Class	2

Premarket Reviews
Manufacturer	Decision
EMD ENDOSZKOP MUSZER GYARTO ES KERESKEDELMI KFT.
	SUBSTANTIALLY EQUIVALENT	1
EVONOS GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Remains Activated	223	223
Fail-Safe Did Not Operate	207	207
Failure to Auto Stop	136	153
Activation, Positioning or Separation Problem	82	82
Break	43	43
Material Separation	38	38
Detachment of Device or Device Component	22	22
Dull, Blunt	19	19
Fracture	19	19
Mechanical Problem	14	14
No Apparent Adverse Event	11	11
Insufficient Device Problem Information	6	6
Adverse Event Without Identified Device or Use Problem	6	7
Entrapment of Device	5	5
Material Disintegration	5	6
Premature Indicator Activation	5	5
Overheating of Device	5	5
Appropriate Device Problem Term/Code Not Available	5	7
Loss of Power	4	4
Electrical /Electronic Property Problem	4	4
Excessive Heating	4	4
Material Integrity Problem	3	3
Positioning Problem	3	3
Material Fragmentation	3	3
Premature Activation	2	2
Mechanical Jam	2	2
Flaked	2	2
Naturally Worn	2	2
Failure to Cut	2	2
Use of Device Problem	2	2
Peeled/Delaminated	2	2
Delivered as Unsterile Product	1	1
Misconnection	1	1
Activation Failure	1	1
Particulates	1	1
Device Dislodged or Dislocated	1	1
Melted	1	1
Difficult to Remove	1	1
Separation Failure	1	1
Material Erosion	1	1
Complete Blockage	1	1
Crack	1	1
Physical Resistance/Sticking	1	1
Intermittent Loss of Power	1	1
Communication or Transmission Problem	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	408	426
Brain Injury	133	135
Perforation	130	130
Insufficient Information	91	94
Abrasion	38	38
Rupture	37	50
Hemorrhage/Blood Loss/Bleeding	36	37
Spinal Cord Injury	17	17
Injury	14	14
Unspecified Tissue Injury	12	12
No Known Impact Or Consequence To Patient	10	10
Foreign Body In Patient	9	9
Laceration(s)	9	9
Dural Tear	9	9
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	7	7
Bruise/Contusion	4	4
Convulsion/Seizure	3	3
Hematoma	3	3
Intracranial Hemorrhage	3	3
Intraocular Pressure Increased	2	2
Unintended Radiation Exposure	2	2
Intraocular Pressure Decreased	2	2
Eye Injury	2	2
Altered State of Consciousness	1	1
No Consequences Or Impact To Patient	1	1
Hyphema	1	1
Perforation of Vessels	1	1
Vitreous Hemorrhage	1	1
Coma	1	1
Visual Impairment	1	1
Ambulation or Postural Difficulties	1	1
Choroidal effusion	1	1
Visual Disturbances	1	1
Flashers	1	1
Burn(s)	1	1
Unspecified Nervous System Problem	1	1
Chemical Exposure	1	1
Inflammation	1	1
Vascular Dissection	1	1
Corneal Decompensation	1	1
Corneal Abrasion	1	1
Inadequate Osseointegration	1	1
Speech Disorder	1	1
Stroke/CVA	1	1
Wound Dehiscence	1	1
Dysphasia	1	1
Corneal Clouding/Hazing	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Integra LifeSciences Corp. (NeuroSciences)	I	Nov-03-2025
2	Integra LifeSciences Corp. (NeuroSciences)	I	May-06-2025