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

Model Number 1001.001

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 08/02/2023

Event Type  Injury  

Event Description

Customer informed us on the 2nd of august that one of our products was involved in a procedure (posterior cervical fusion) in which a laceration occured to the patient.

Manufacturer Narrative

None of the findings of this investigation could have been a causative factor for the incident described by the customer.Both findings of this investigation (worn thread insert and roughened surface of the extension arm) are due to insufficient lubrication of the skull clamp.The detailed specifications for maintenance and care (cleaning, lubrication, servicing) of the product are mandatory in the associated ifu.As none of the deviations detected during this investigation could have caused 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.".

• 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
• MDR Report Key: 17639610
• MDR Text Key: 322134916
• Report Number: 3003923579-2023-00023
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435506196
• UDI-Public: 04250435506196
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1001.001
• Device Catalogue Number: 1001.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/02/2023
• Device Age: 53 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other