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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFINITY¿ NAVIGATED OCT SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC SOFAMOR DANEK USA, INC INFINITY¿ NAVIGATED OCT SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number NAV3606195
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2022
Event Type  malfunction  
Event Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a driver used in posterior cervi cal fusion spinal therapy. It was reported that infinity driver jammed up inside the navlock. There was no patient symptom reported. There were no further complications reported regarding the event.
 
Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameINFINITY¿ NAVIGATED OCT SYSTEM
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key13838195
MDR Text Key289086511
Report Number1030489-2022-00269
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173338
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNAV3606195
Device Catalogue NumberNAV3606195
Device Lot NumberCA20F065
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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