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TPLC
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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
Premarket Reviews
Manufacturer
Decision
PRO MED INSTRUMENTS GMBH
SUBSTANTIALLY EQUIVALENT
5
MDR Year
MDR Reports
MDR Events
2020
607
607
2021
512
512
2022
268
268
2023
265
265
2024
197
197
2025
123
123
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
Recalls
Manufacturer
Recall Class
Date Posted
1
Deerfield Imaging, Inc.
II
Apr-14-2022
2
Integra LifeSciences Corp.
II
Dec-08-2020
3
Pro-Med Instruments Gmbh
II
May-28-2025
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