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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 4.75 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA 4.75 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 54840005545
Device Problem Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2020
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Information was received from the healthcare professional (hcp) via manufacturer representative regarding an event that occurred during a spinal fusion procedure on a patient diagnosed with laminectomy and discectomy. It was reported that when hcp attempted to break off the set screw the set screw did not break off and continued to turn in the screw. There was a delay of approximately 30 minutes in the procedure. A revision surgery was performed for removal of set screws, rod and problem screw unilaterally and reinsertion of replacement screw, rod and set screw. The product will be returned, and was replaced with a medtronic product. No patient complications were reported.

 
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Brand NameCD HORIZON SOLERA 4.75
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 Key10394666
MDR Text Key202510323
Report Number1030489-2020-01072
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeSF
PMA/PMN NumberK091974
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number54840005545
Device Catalogue Number54840005545
Device LOT NumberH5522684
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/28/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/28/2019
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: 08/12/2020 Patient Sequence Number: 1
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