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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 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number G9010001550
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2022
Event Type  malfunction  
Event Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for lumbar spinal stenosis. Level at which implant was performed : l4/5 it was reported that when an attempt was made to fasten the center of the hexagonal screw during cross-link installation, it could not be tightened, and the final conclusion could not be performed.  the device was replaced with a different one and completed. There was a delay in the procedure by less than 60 mins. The device was never implanted.  there was no patient symptom reported. There were no further complications reported regarding the event. Additional information: procedure: posterior lumbar fusion the product came in contact with the patient.
 
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.
 
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Brand NameCD HORIZON® 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
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key14139794
MDR Text Key289994704
Report Number1030489-2022-00365
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153589
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG9010001550
Device Catalogue NumberG9010001550
Device Lot NumberH5729065
Was Device Available for Evaluation? No
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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