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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® QR3 SKULL CLAMP

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PRO MED INSTRUMENTS GMBH DORO® QR3 SKULL CLAMP Back to Search Results
Model Number 1001.001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 09/23/2021
Event Type  Injury  
Manufacturer Narrative
As the device had a minor deviation on 2 of 4 measuring points, it generally cannot be excluded that the device has contributed to the event.However given the minor degree (5n and 7n below tolerance) of the deviation it is very unlikely that the device has contributed to the event.It can not be excluded that the combination with the third party pins contributed to the reported incident.The possibility of slippage increases when using pins with a blunt tip.The fixation of the patient is realized by the pressure applied at the pin tip.Pressure is p=f/a ;with f=force and a=area.A blunt pin results in increased area and if the force remains the same, reduced pressure is the result.This results in a reduced fixation, increasing the risk of slippage (compare zaazoue et al.2017).The customer informed us that the positioning of the patient was changed during the surgery without loosening the connections or changing the adjustment of the headrest system.It can not be excluded that this also contributed to the reported incident.We suspect, that maybe the pinning technique has been not optimal as described in the instruction manual: "adjust the skull clamp to the width of the patient's head in the manner that the two skull pins in the rocker arm are equidistant from the centerline of the head and the single skull pin at the extension assembly is in line with this centerline.".
 
Event Description
Distributor informed our service department on the 20th of october that one of our products was involved in a case where a laceration occured.
 
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Brand Name
DORO® QR3 SKULL CLAMP
Type of Device
DORO® QR3 SKULL CLAMP
Manufacturer (Section D)
PRO MED INSTRUMENTS GMBH
boetzinger str. 86
freiburg, baden-wuerttemberg 79111
GM  79111
Manufacturer (Section G)
PRO MED INSTRUMENTS GMBH
boetzinger str. 86
freiburg, baden-wuerttemberg 79111
GM   79111
Manufacturer Contact
christopher schmitz
boetzinger str. 86
freiburg, baden-wuerttemberg 79111
GM   79111
MDR Report Key12811615
MDR Text Key285257027
Report Number3003923584-2021-00020
Device Sequence Number1
Product Code HBL
UDI-Device Identifier04250435506196
UDI-Public04250435506196
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K001808
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1001.001
Device Catalogue Number1001.001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2021
Initial Date Manufacturer Received 10/20/2021
Initial Date FDA Received11/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age59 YR
Patient SexFemale
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