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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PROBE

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MEDTRONIC SOFAMOR DANEK USA, INC PROBE Back to Search Results
Catalog Number 7480112
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2019
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.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient underwent lumbar fusion surgery due to unknown reason.Intra-op, the end of probe broke off and was easily retrieved.No fragments of the instrument remaining in the patient body.No patient complications were reported due to this event.
 
Manufacturer Narrative
Product analysis results: visual observation reveals that the tip of the probe has been sheared off and is missing from what appears to be overload.Hardness reveals that the probes are the proper hardness.This is consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PROBE
Type of Device
PROBE
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
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key9339633
MDR Text Key184898575
Report Number1030489-2019-01314
Device Sequence Number1
Product Code HXB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
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 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7480112
Device Lot Number383717
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age52 YR
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