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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 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA VOYAGER SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 54750016545
Device Problems Break (1069); Misassembly by Users (3133)
Patient Problem Thrombosis (2100)
Event Date 10/02/2019
Event Type  Death  
Manufacturer Narrative
Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the r eported event. Although it is unknown whether this product caused or contributed to the reported event, we are filling this mdr for notification purpose. H10: hcp review results: this event is related to the surgery and has no cause-effect relationship with the device. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient underwent percutaneous pedicle screw fixation at posterior side of t11-l5 due to l2 vertebral body fracture from a tumble. Intra-op, the set screw on the left side of l3 did not engage with the screw even though it was pushed. Although the set screw was caught on, it idled during tightening. The tab extender cap had been attached, but the tab of the screw broke; so, the surgeon tried skin incision but the set screw did not engage. The screw was explanted and a bigger set screw was inserted again. There was a gap noted between the rod and the screw head as well. The procedure was delayed by less than 60 minutes due to this event. Post-op, after final tightening and wound closure was done without problems, when patient's position was changed to supine position, patient's condition had a sudden deterioration and the nurse reported the color of patient's feet was not good. The condition turned to a cardiac arrest state and treatment was performed at the operation room for more than an hour. The reason suspected for health deterioration was reported that when setting position, although vertebral body reduction had been performed, it was felt that the anterior side of the vertebral body opened during the operation. According to the doctor, this occurred maybe because the pillow placed at the abdomen displaced during the operation, and the unintended part was pressed due to the displacement. The patient was then transferred to icu in the state that "vf" still did not return. Then, at a later date, on (b)(6) 2019, it was heard that the patient had died. The cause of death was reported as pulmonary thrombosis. The doctor reported that the death was attributable to the release from the compression of groin; and not related to the malfunction of the implant. When checking the screw, some scratches were noted on a part of the tab threads while the threads of the screw appear to have no problem.
 
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Brand NameCD HORIZON SOLERA VOYAGER SPINAL SYSTEM
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
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key9264987
MDR Text Key164573170
Report Number1030489-2019-01237
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00643169501065
UDI-Public00643169501065
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K143375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number54750016545
Device Lot NumberH5395353
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2017
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: 11/01/2019 Patient Sequence Number: 1
Treatment
SET SCREW, ROD
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