MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, SPINOUS PROCESS TALL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734715

Device Problem Break (1069)

Patient Problems Spinal Column Injury (2081); Tissue Damage (2104)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Device returned to the manufacturer for analysis.A visual analysis confirmed that clamp was damaged.

Event Description

Medtronic received information regarding a navigation system being used for a sacroiliac and thoracolumbar.It was reported that the tall spine clamp was damaged while trying to remove it.The washer broke off the clamp.The spinous process was fracture when trying to remove the clamp.

Event Description

Additional information was received on 7/9/2018.The piece of the clamp that was damage was recovered and discarded by the site.No foreign objects were left in the body.

• Brand Name: CLAMP, SPINOUS PROCESS TALL
• Type of Device: ORTHOPEDIC 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: parker desautel ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7665004
• MDR Text Key: 113269832
• Report Number: 1723170-2018-03171
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00643169936300
• UDI-Public: 00643169936300
• 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,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 9734715
• Device Lot Number: 160628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2018
• 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 Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 79