MAUDE Adverse Event Report: PRO MED INSTRUMENTS DORO SKULL CLAMP RADIOLUCENT (3-PIN HFD); HEAD HOLDER, SKULL CLAMP

Model Number 4001-20

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problem Skull Fracture (2077)

Event Date 12/07/2015

Event Type  Injury  

Manufacturer Narrative

Device not send in.

Event Description

Our customer reported the following event in report no.2233020000-2015-8016.# event description (summary of mdr report from our customer): a (b)(6) patient was underwent a posterior fossa craniotomy for tumor resection with intraoperative mri.For mri removing the patient from the pinning was necessary.After mri a second pinning was required.During this second pinning, it was noted, that one of the pins did not register pressure as it was being tightened.The torque screw was changed.The torque screw and pin had 45 pounds of pressure applied.When surgical drapes were removed, there was bleeding noted at pin site located in the left temporal area.When pin was removed, some bleed drained through a laceration secondary to the pin and the epidural space could be visualized indicating a skull fracture.Other patient information: because of the need to remove residual tumor, patient had pins placed multiple times possibly weakening the skull.

Manufacturer Narrative

We only received the torque screw that was involved in the reported incident.Sn of torque screw: (b)(4).Manufacturing no.Of skull clamp: unknown.

Event Description

Our customer reported the following event in report no.(b)(4).We already transmitted initial report at 07.03.2016 to fda.This is report follow-up #1.

• Brand Name: DORO SKULL CLAMP RADIOLUCENT (3-PIN HFD)
• Type of Device: HEAD HOLDER, SKULL CLAMP
• Manufacturer (Section D): PRO MED INSTRUMENTS; boetzinger str. 38; freiburg, baden württemberg 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS; boetzinger str. 38; freiburg, baden württemberg 79111 ; GM 79111
• Manufacturer Contact: erasmus baumann ; boetzinger str. 38; freiburg, baden-württemberg 79111 ; GM 79111 ; 761384222
• MDR Report Key: 5520093
• MDR Text Key: 40989040
• Report Number: 3003923584-2016-00002
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4001-20
• Device Catalogue Number: 4001-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR
• Patient Weight: 38