CD HORIZON SPINAL SYSTEM UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for CD HORIZON SPINAL SYSTEM UNK manufactured by Medtronic Sofamor Danek Usa, Inc..

Event Text Entries

[186752308] Product was not 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.
Patient Sequence No: 1, Text Type: N, H10


[186752309] It was reported that: on (b)(6) 2020: the patient presented with the pre-operative diagnoses of broken rods and pseudoarthrosis. She underwent posterior lumbar fusion with transforaminal lumbar interbody fusion at l3-s1. After 1 week post-op, the patient heard a huge pop. On (b)(6) 2020: ct scan was performed due to right low back pain and pop sound. Impressions: 1. Interval anterior interbody fusion at l4-l5. 2. Posterior instrumentation with interval revision. Interruption involving the right l3 transpedicular screw, possible fracture right l3 transpedicular screw. 3. Mild displaced fracture involving right transverse process of l3, acute, subacute or chronic. The patient also underwent x-rays, which showed top two screws broken on a l3-s1 surgery. On (b)(6) 2020: the patient met with her surgeon to discuss about the revision surgery to be scheduled. The patient was given a back stabilizer and sent home.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2020-00399
MDR Report Key9902632
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-18
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTACIE ZIEMBA
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1MEDTRONIC SOFAMOR DANEK USA, INC.
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal Code38132
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCD HORIZON SPINAL SYSTEM
Product CodeNKB
Date Received2020-03-31
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SOFAMOR DANEK USA, INC.
Manufacturer Address1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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