MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® STERILE DISPOSABLE SKULL PIN; DORO® SKULL PIN

Model Number	3006-20
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing further information will be provided as soon as possible.
Event or Problem Description
Customer service was contacted on (b)(6) 2018 from customer.Customer stated: "today in a surgeon's imri case we used 2 packs of the head pins.1 of the head pins was not mri safe.This was determined by the artifact captured on the mri scan and placing a magnet over all head pins and 1 of them instantly reacting to the magnet placed over it.All safety precaution steps have been taken since this discover".
Event or Problem Description
No additional information in this follow-up.

• Brand Name: DORO® STERILE DISPOSABLE SKULL PIN
• Common Device Name: DORO® SKULL PIN
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 8235141
• Report Number: 3003923584-2018-00067
• Device Sequence Number: 1947436
• Product Code: HBL
• UDI-Device Identifier: 04250435501092
• UDI-Public: 04250435501092
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K001808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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?: Yes
• Operator of Device: No Information
• Device Model Number: 3006-20
• Device Catalogue Number: 3006-20
• Device Lot Number: 18041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1