MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

Catalog Number 55750017540

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 01/20/2020

Event Type  malfunction  

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.

Event Description

It was reported that the patient presented with lumbar canal stenosis.She underwent combined anterior-posterior fixation at l3-l5, oblique lumbar interbody fusion at l3-l4 and l4-l5, right/left percutaneous pedicle screw fixation at l3-l5 in decubitus position and l3-l4 compression.Navigation and fluoroscopy was used in this procedure.Compression procedure was being performed from the left side to the right side.During the compression procedure, the intervertebral disc space was found a little narrow; therefore, it was lifted up a little with the trial.After that, the screw was inserted.When compression was applied to the alleged intervertebral disc space, tip of the screw at l3 on the right moved to the cranial side inside the vertebral body around the pedicle as a result of compression on the right side.In the view of sales rep, the compression had been heavily loaded.The procedure was delayed by less than 60 minutes as a result of this event.There is no plan to explant the deviated screw.It is unknown if there were any patient complications as a result of this event.

• Brand Name: CD HORIZON SOLERA VOYAGER SPINAL 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9701529
• MDR Text Key: 179283073
• Report Number: 1030489-2020-00169
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169783904
• UDI-Public: 00643169783904
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170679
• 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
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 55750017540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR