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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON BALLAST SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON BALLAST SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 25100401
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/25/2020
Event Type  Injury  
Manufacturer Narrative
Device fragments in patient. 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 intra-op, tip of screw driver is sheared off and remained in the head of the screw. This was unable to be retrieved. The patient was able to have solid fixation once the procedure was completed. No patient complications were reported.
 
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Brand NameCD HORIZON BALLAST SPINAL SYSTEM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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 Key9881940
MDR Text Key185035964
Report Number1030489-2020-00375
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K153442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number25100401
Device Lot NumberCT16E0561
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/26/2020 Patient Sequence Number: 1
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