MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, THORACIC, RADIOLUCENT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9733148

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.

Event Description

A site representative reported that, while outside of a procedure, the spine clamp was stripped.There was no patient present when this issue was identified.No additional information was provided.

• Brand Name: CLAMP, THORACIC, RADIOLUCENT
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7125970
• MDR Text Key: 95747506
• Report Number: 1723170-2017-05198
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994201263
• UDI-Public: 00613994201263
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9733148
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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