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

Catalog Number	55750017540
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Outcomes attributed to adverse event: other: pedicle fracture.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 transforaminal lumbar interbody fusion (tlif) at l4-l5 due to grade 2 spondylolisthesis at l4.Intra-op, when checking the frontal image after final tightening, it was found that the screw on the left side of l4 came off to the lateral side.After screw insertion, it was checked that the screw had entered the vertebral body; hence, the surgeon considered that there was a high possibility that the pedicle had fractured during compression or final tightening.It was suspected that bone fracture had occurred since the state was unstable.Then, the implanted set screw, rod and screw were removed; and after inserting a screw of bigger size, the rod and set screw were re-inserted.The operation was then finished after final tightening.There was a delay of less than 60 minutes in overall procedure.Bone quality was determined to be bad by the surgeon.

• 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: 9859612
• Report Number: 1030489-2020-00339
• Device Sequence Number: 19660090
• Product Code: NKB
• UDI-Device Identifier: 00643169783904
• UDI-Public: 00643169783904
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2020

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: 55750017540
• Device Lot Number: H5576506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/20/2020
• 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: Other