MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC OPEN SPINE CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9731780

Device Problem Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2022

Event Type  malfunction  

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.The spine clamp was damaged.There was fixation failure due to abrasion at the spike region.There was no patient involvement.

Manufacturer Narrative

Analysis found on the clamp- analysis determined the returned clamp has a few bent or blunted tips on the spiked surfaces of the two clamp faces.The clamp is otherwise fully functional.If information is provided in the future, a supplemental report will be issued.

• Brand Name: OPEN SPINE CLAMP
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14053618
• MDR Text Key: 288896785
• Report Number: 1723170-2022-00523
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K990214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9731780
• Device Catalogue Number: 9731780
• Device Lot Number: 160818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2016
• 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