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U.S. Department of Health and Human Services

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

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 54850016545
Device Problem Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/24/2020
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from the distributor via manufacturer representative for an event which occurred during the l3-l5 mis-tlif surgery in patient diagnosed with hivd. It was reported that the surgeon spun the break-off handle, but it failed to listen the sound 'pia' and were broken off successfully. The surgeon replaced with the another set screw, it was in the same situation. The surgeon replaced with the another set screw, it was in the same situation. The surgeon unscrewed the screw and replaced with the new screw and set screw, it succeeded to be broken off and complete the surgery. Product will be returned, and it was replaced with medtronic product. No patient injury / complication was reported.

 
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Brand NameCD HORIZON SOLERA 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 Key11162025
MDR Text Key226545215
Report Number1030489-2021-00064
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeTW
PMA/PMN NumberK143375
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 06/04/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/13/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number54850016545
Device Catalogue Number54850016545
Device LOT NumberH5627448
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/20/2021
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/10/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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