MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) OPEN SPINE CLAMP DRIVER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9730027

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

Event date is approximate.Unique device identification (udi) is unavailable.Device manufacturing date is unavailable.No parts have been received by the manufacturer for evaluation.Part not returned.

Event Description

Medtronic received information regarding a navigation instrument.It was reported that the open spine driver was damaged.Specifically, the instrument was reported to be bent.This was noticed outside of surgery.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.

• Brand Name: OPEN SPINE CLAMP DRIVER
• 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 ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7516694
• MDR Text Key: 108358535
• Report Number: 1723170-2018-02054
• Device Sequence Number: 1
• Product Code: HAW
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9730027
• Device Lot Number: 120207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2012
• 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