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

Model Number 3003-009

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

No evaluation possible as the device was not returned.

Event Description

Customer stated: "swivel arm slipped while positioning patient.Was there a risk for a person/patient resulting by the use of the medical device? yes.Please describe risk (and possible injuries): 5 cm laceration left scalp.Procedure being performed: posterior cervical fusion.Patient positioning: prone.Was the surgery completed? yes.Date of incident: (b)(6) 2018.

Manufacturer Narrative

This is follow-up 1: the device was received on 03rd december 2018.Conducted visual and functional testing/inspection.Result: torque screw pin pressure deviation (slightly too low).Some dings were noted on the surface of the device.Concerning the reported event: 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 Description

No additional information in this follow-up.

• Brand Name: DORO® SKULL CLAMP
• Type of Device: DORO® SKULL CLAMP
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 8127972
• MDR Text Key: 129149373
• Report Number: 3003923584-2018-00058
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K001808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

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
• Device Operator: No Information
• Device Model Number: 3003-009
• Device Catalogue Number: 3003-009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 11/05/2018
• Supplement Dates FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1