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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK
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MEDTRONIC SOFAMOR DANEK Back to Search Results
Device Problem Metal Shedding Debris (1804)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2016
Event Type  malfunction  
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.
 
Event Description
It was reported that the patient underwent posterior lumbar interbody fusion surgery at l2-l3 levels, for the treatment of spinal canal stenosis.Intra-op, at the time of inserting a set screw to a t-bolt connector, cross-threading occurred.Burr was generated during inserting the set screw into the connector.The set screw and the connector were replaced.The product came in contact with the patient.No patient complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5821271
MDR Text Key51447385
Report Number1030489-2016-02175
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/28/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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