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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 54850016545
Device Problems Use of Device Problem (1670); Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from healthcare professional via field representative regarding patient with unknown indication involved in the reported event. It was reported that intra-operatively, after implanting four pedicle screws and securing the rods, the physician proceeded to remove the screw extender from the implanted screws. However, when post op films were performed, noticed one of the screw tulips had not broken off with the extenders. On 2021-sep-03, received additional information that doctor didn't realize the screw tulip was still attached to the screw until two days later after they took post-operative films. Screw was implanted at l4 on the right side. The therapy involved in the event was a tlif at l4/5. Extender was disposed after use. It was reported that, extender could have failed to break off the extender, but it could have also not been fully locked onto the screw tulip. Labeling and ifu were followed throughout the procedure. Patient was not hospitalized longer due to the event. As of now, doctor sees no reason to reoperate/address the issue. So, there is no revision surgery date.
 
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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
david gustafson
1800 pyramid place
memphis, TN 38132
7635149628
MDR Report Key12479538
MDR Text Key271657891
Report Number1030489-2021-01167
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number54850016545
Device Catalogue Number54850016545
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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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