MAUDE Adverse Event Report: NORTHERN DIGITAL INC. NDI PASSIVE SPHERES; REFLECTIVE PASSIVE MARKER SPHERES

Model Number 8801071

Device Problem Data Problem (3196)

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

Event Date 01/09/2015

Event Type  malfunction  

Manufacturer Narrative

Device discarded by user.

Event Description

This event was communicated by medtronic navigation who reported that a site had spheres that did not track.Site did not record lot information, did not take pictures and disposed of the product.Site replaced spheres and the new spheres were able to track.Complainant did not report any patient/user injury, death or other serious deterioration in health.

• Brand Name: NDI PASSIVE SPHERES
• Type of Device: REFLECTIVE PASSIVE MARKER SPHERES
• Manufacturer (Section D): NORTHERN DIGITAL INC.; 103 randall drive; waterloo, ontario N2V 1 C5; CA N2V 1C5
• Manufacturer (Section G): IIMAK MEXICANA S. DE R.L. DE C.V.; brecha e99 l15e; parque industrial reynosa; reynosa tam, CP887 80; MX CP88780
• Manufacturer Contact: gord wehner ; 103 randall drive; waterloo, ontario N2V 1-C5 ; CA N2V 1C5 ; 8845142
• MDR Report Key: 4925046
• MDR Text Key: 22519800
• Report Number: 3002743211-2015-00039
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 01/16/2015

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: Other
• Device Model Number: 8801071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly