MAUDE Adverse Event Report: MRI INTERVENTIONS, INC. HEAD FIXATION FRAME; HOLDER HEAD, NEUROSURGICAL

Model Number	ED-800116
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event is incidental to the use of the device, not exceptional in frequency.Device not returned to manufacturer.
Event or Problem Description
Case required a prone position.Difficulty was experienced in the prone positioning, resulting in puncture wounds in the right temple and forehead, such that the ptx required repositioning to supine for closure of the wounds.Right forehead required only pressure to stabilize; the temple required two sutures to close the wound.Estimated bloods lose at 25-50ml.
Additional Manufacturer Narrative
No additional findings upon receipt of product lot number.

• Brand Name: HEAD FIXATION FRAME
• Common Device Name: HOLDER HEAD, NEUROSURGICAL
• Manufacturer (Section D): MRI INTERVENTIONS, INC.; 5 musick; irvine CA 92618
• MDR Report Key: 6873554
• Report Number: 1125732-2017-00002
• Device Sequence Number: 10897279
• Product Code: HBL
• UDI-Device Identifier: 00850376007031
• UDI-Public: 00850376007031
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 091439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ED-800116
• Device Catalogue Number: CP-MPHFF-332-01
• Device Lot Number: FA1611014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 73