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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 54850016545
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2020
Event Type  Injury  
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
Information was received from a regulatory body via a manufacturer representative regarding a patient with pre-operative diagnosis of percutaneous olif. It was reported that post-op, stem disconnection was discovered on x-ray. The patient was operated with a percutaneous voyager solera implant. Third week after this first surgery, surgeon was in operative room for the olif surgery but the surgeon discovered the disconnection between the setscrew, the screw and the rod. Olif surgery was performed to remove off the rod, screws and setscrews disconnected and to introduce new percutaneous voyager solera implants. As per surgeon the thread of the set screw was not connected well with the head of the screw. Product was utilized correctly according to the directions given in the ifu/labeling. There were no patient symptoms/ complications associated with the event.
 
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Brand NameCD HORIZON SPINAL SYSTEM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer (Section G)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer Contact
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key11035962
MDR Text Key222304886
Report Number1030489-2020-01819
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K170679
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 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number54850016545
Device Catalogue Number54850016545
Device Lot NumberH5609262
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/18/2020 Patient Sequence Number: 1
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