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

Catalog Number	55750016545
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 l3.Along with the alleged screw, the screw at right side of l2 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.

• 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
• MDR Report Key: 9682383
• Report Number: 1030489-2020-00154
• Device Sequence Number: 19499936
• Product Code: NKB
• UDI-Device Identifier: 00643169783843
• UDI-Public: 00643169783843
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 55750016545
• Device Lot Number: H5572705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2020
• Initial Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention