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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® SPINAL SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® SPINAL SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number NAV2024K
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/03/2021
Event Type  malfunction  
Event Description
Information was received from a healthcare provider (hcp) via manufacturer representative regarding a patient with an unknown indication for l4/5 rlif with l5/s1 hardware revision of previous fusion (b)(6) 2019 globus. It was reported that the surgeon removed globus hardware from l5/s1 and replaced it with mdt, adding a tlif to l4/5. The screw that the driver broke off on was rl5. The broken off part of the screw driver shank could not be removed and remained in the screw shank. It did not hinder rod placement.  product will be returned. There were no patient symptoms or complications reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameCD HORIZON® SPINAL 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 Key13095160
MDR Text Key288800614
Report Number1030489-2021-01593
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140454
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 06/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNAV2024K
Device Catalogue NumberNAV2024K
Device Lot NumberCA15G112
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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