MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CLAMP 9734716 SPINOUS PROCESS SHORT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734716

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

Patient weight unavailable.No devices were returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a sacroiliac and thoracolumbar procedure.It was reported that the screw and washer came off the clamp.No parts were left in the patient.There was no delay to the case and no patient impact was correlated with this event.2019-dec-21 (rep) new information received: patient weight unavailable.

• Brand Name: CLAMP 9734716 SPINOUS PROCESS SHORT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9516045
• MDR Text Key: 175916847
• Report Number: 1723170-2019-06152
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9734716
• Device Catalogue Number: 9734716
• Device Lot Number: 160707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2016
• 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 Age: 76 YR