MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA VOYAGER SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 54750016545

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Product was not 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.

Event Description

It was reported that the patient presented with l3-l5 lumbar spinal canal stenosis; and underwent mono-portal transforaminal lumbar interbody fusion (tlif) at l3-l5.Tlif was performed from l3-l4 after decompression, and the surgeon began to perform posterior fixation by wiltz approach after performing tlif at l4-l5.Pedicle screw insertion was performed from l3 on the right side, and screw insertion and final tightening were completed at l3-l5 on the right side successfully.Pedicle screw insertion was started from l3 on the left side, and the pilot holes of the screws up to l5 were prepared, and sagittal image was confirmed.Insertion was performed again at l4 and l5, and pedicle screws were inserted starting from l3.When the rod was inserted, it seemed that l4 screw was obviously outside.Set screw was dropped in the screw and was tightened; but idling occurred.The set screw was then replaced with another one; but still the idling occurred.All of the set screws and the rod were removed, and the screw at l4 was removed, and another screw with a diameter of 7.5 x 45mm was inserted again.After that, the rod was inserted again, but it still felt strange and idling still occurred.For that reason, the surgeon pulled back the screw head of l4 a little to adjust the depth, and final tightening was performed successfully.It was considered that maybe the rod¿s reverse force against the set screw worked.There were no patient complications as a result of this event.

Manufacturer Narrative

Product analysis: visual and optical inspection confirmed the reduction extension part of the head is bent, dis-allowing proper insertion of the set screws.The crown and the female torx of the screw show some wear from the driver engagement and the seating of the rod.The break-off portion of the threads are undamaged.This type of damage is consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
• Type of Device: ORTHOSIS, 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 Key: 9469352
• MDR Text Key: 179316428
• Report Number: 1030489-2019-01420
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169501065
• UDI-Public: 00643169501065
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 54750016545
• Device Lot Number: H5514078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR