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

Catalog Number 55750016545

Device Problem Migration or Expulsion of Device (1395)

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

Event Type  Injury  

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 underwent percutaneous pedicle screw placement at l2-l3, crosslink placement was performed at s1, screw insertion was performed at s2ai and rods were inserted on both sides.On an unknown date, post-op, the screw backed-out at right side of l2.Along with the alleged screw, the screw at right side of l3 backed-out; and left side of the crosslink at s1-s2ai deviated (backed-out) from sacrum.Hence, a revision surgery, was performed, in which, the backed-out crosslink was explanted and was replaced with a new one.The backed-out screws were removed; and were replaced with screws of bigger size, with change in insertion angle.Rod placement was performed again.Additional crosslink placement was performed between l2-l3.The procedure was then completed.There was a delay of more than 60 minutes in overall procedure.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 9682314
• MDR Text Key: 178175998
• Report Number: 1030489-2020-00153
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169783843
• UDI-Public: 00643169783843
• 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,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 55750016545
• Device Lot Number: H5572705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2019
• 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 Outcome(s): Required Intervention