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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 VOYAGER SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA VOYAGER SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 55750017545
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); Intraoperative Pain (2662)
Event Date 10/13/2021
Event Type  Injury  
Event Description
Information was received from a healthcare provider via a manufacturer representative regarding a patient with spinal therapy. It was reported that the set screw backed out. The l4 screw was also a little loose. As the back pain worsened, additional surgery performed to remove the screws and replace them. Since there was a possibility that the dorsal side of the left cage (capstonepeekptc) that had been placed was interfering with the nerve root, the posterior decompression of the left side was also performed additionally since the cage was sinking. There were no further complications reported regarding the event. The allegation of screw is looseness. There was no defect with the rod.
 
Manufacturer Narrative
Evaluation of the returned device was not completed at the time of this report. A follow up report will be sent when analysis is complete. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameCD HORIZON SOLERA VOYAGER 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 Key12818125
MDR Text Key280808368
Report Number1030489-2021-01392
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00643169783911
UDI-Public00643169783911
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K170679
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number55750017545
Device Catalogue Number55750017545
Device Lot NumberH5685263
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2021
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: 11/16/2021 Patient Sequence Number: 1
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