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	54750014540
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)
Date of Event	06/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of 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 posterior spinal fusion at t8-l2 due to t11 fracture dislocation (3a3b).Post-operative wound infection occurred and as a result the screw on the right side became loose.The patient underwent revision surgery for removal of the screw.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
• Common Device Name: 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
• MDR Report Key: 7685770
• Report Number: 1030489-2018-00993
• Device Sequence Number: 16314650
• Product Code: NKB
• UDI-Device Identifier: 00643169501171
• UDI-Public: 00643169501171
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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 Expiration Date: 07/06/2023
• Device Catalogue Number: 54750014540
• Device Lot Number: H5198432
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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