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

Model Number	4003.001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible as the device was not returned.
Event or Problem Description
Customer service was contacted on (b)(6) 2019 by customer.Customer stated, that the surgeon had a slippage.
Additional Manufacturer Narrative
This is follow-up 1: the device was received on 13th september 2019.Conducted visual and functional test / inspection.Result: pin pressure is out of specifications.Interval of the supplier maintenance was exceeded by the customer.As the device was out of specification, it generally cannot be excluded that the device has contributed to the event.From our experience 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 or Problem Description
No additional information in this follow-up.

• Brand Name: DORO® SKULL CLAMP RADIOLUCENT
• Common Device Name: DORO® SKULL CLAMP RADIOLUCENT
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, 79111 ; GM 79111
• MDR Report Key: 9021140
• Report Number: 3003923584-2019-00024
• Device Sequence Number: 2451605
• Product Code: HBL
• UDI-Device Identifier: 04250435516232
• UDI-Public: (01)04250435516232
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4003.001
• Device Catalogue Number: 4003.001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1