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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 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 54850016540
Device Problem Break (1069)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/08/2021
Event Type  Malfunction  
Manufacturer Narrative

Radiographic image assessment - an interbody graft is present in post op x rays for l5-s1 fusion. There is a steep sacral slope and a paucity of bone present in the interbody space. Both of the sacral screws are fractured. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from healthcare professional via manufacturer representative regarding a patient who had fusion l5/s1 due to scoliosis. It was reported that the doctor found out that the screw heads were apart from the screw body in ct. There were no patient symptoms/ complications as a result of the event.

 
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Brand NameCD HORIZON SOLERA SPINAL SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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 Key11936659
MDR Text Key256201266
Report Number1030489-2021-00735
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
Report Date 06/04/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/03/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number54850016540
Device Catalogue Number54850016540
Device LOT NumberH5600318
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/29/2020
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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